Ortho Clinical Diagnostics enGen Automation
Ortho Clinical Diagnostics · Model enGen Automation
• Auto-verify valid results • Boost productivity by processing more samples during all shifts without adding staff • MICROSLIDE/MICROTIP Technology ensures low maintenance • Balance workloads and eliminate workstation bottlenecks • Reduce exposure to biohazards • Results-based Routing handles re-runs, dilutions, and reflex testing without operator intervention • Streamline sample handling by eliminating operator interventions • Reduce time spent searching for with automated Sample Tracking • Eliminate barcode reading errors • Increase first-pass yields • Auto-verification combined with INTELLICHECK Technology delivers worry-free results • Results-based Routing optimizes workflow • Standardize turnaround times • Reduce potential for errors with fewer manual interventions • MICROSENSOR Technology ensures specimen integrity • Lower total cost by improving staff utilization while reducing errors and manual interventions • Expand functionality when lab is ready - start with preanalytical and simply add module or analyzer interfaces as you need them
Key tips
- ·Run QC controls before trusting any repair - an analyzer that passes self-test can still report clinically wrong results.
- ·Rule out a reagent lot change before opening the instrument - it can look exactly like a hardware fault.
- ·Centrifuge rotors have a hard retirement age/cycle limit regardless of visible condition - don't eyeball it.
Typical Failure Modes
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
Sample probe / pipette clog
MediumSymptoms: Aspiration error, short sample, carryover.
Root cause: Clot/crystal obstruction.
Centrifuge imbalance / bearing
HighSymptoms: Vibration, loud noise, stop error.
Root cause: Worn bearing or unbalanced rotor.
Temperature control fault
MediumSymptoms: Incubator out of range.
Root cause: Failed heater/fan or sensor.
Optics / lamp degradation
LowSymptoms: Low signal, wavelength drift.
Root cause: Lamp/LED or monochromator aging.
Serviceable Parts & Consumables
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
Sample aspiration probe
Frequent R&R on high-throughput analyzers.
Class Periodic replacementRel. cost $$$R&R Moderate
Peristaltic pump tubing
Consumable, replace proactively.
Class Frequent wear itemRel. cost $R&R Easy
Xenon / LED light source
Class Periodic replacementRel. cost $$$R&R Moderate
Centrifuge rotor & bearings
Class Major service partRel. cost $$$R&R Difficult
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Sample aspiration probe Frequent R&R on high-throughput analyzers. | Periodic replacement | $$$ | Moderate |
| Peristaltic pump tubing Consumable, replace proactively. | Frequent wear item | $ | Easy |
| Xenon / LED light source | Periodic replacement | $$$ | Moderate |
| Centrifuge rotor & bearings | Major service part | $$$ | Difficult |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Daily QC controls run and reviewed
- ·Calibration verification per assay
- ·Routine cleaning and decontamination
- ·Scheduled reagent-path and pump-tubing maintenance
Troubleshooting Approach
A structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Sample probe / pipette clog
- Confirm the presentation - typically aspiration error, short sample, carryover - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: clot/crystal obstruction.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the sample aspiration probe per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Symptom: Reagent / wash flow fault
- Confirm the presentation - typically clogs, high blank, QC fail - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: pump tube wear, air in line.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the peristaltic pump tubing per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Central / core laboratory
- Point-of-care testing stations
- Blood bank
- Microbiology lab
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track
- RECALL
Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-associated sample IDs involving the communication between enGen TCAutomation (TCA) Bypass modules (manufactured by Thermo-Fisher Scientific) and the VITROS Analyzers. To date, no occurrences of this issue have been observed on Orthos enGen(TM) Systems. Sample IDs may become miss-associated with the actual sample being processed due to discrepant information passed to the analyzer through InOut communication device, triggered by a specific set of events occurring between the Bypass module and the analyzer. --- All of the following conditions must be present for the issue to potentially occur: (1.) The Bypass module is in the process of positioning Sample A at the aspiration position, and (2.) At least two additi
- RECALL
Ortho confirmed that it is possible for the mis-association of sample identification and assay results due to an error with Thermo Fishers centrifuge module. It is possible for mis-associated assay results to be reported from the laboratory prior to the identification of the Cross Check error on the enGen Laboratory Automation System. Assay results associated with the wrong patient and reported out of the laboratory could lead to inappropriate intervention with the potential for serious injury to the patient.
- RECALL
If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results fall between Negative and Reactive, the IM incorrectly displays the interpretive text as Borderline and sends the incorrect text to the LIS. The IFU states the interpretation term for these numerical result values is Retest?. The difference in terminology exists for US Markets only.
- RECALL
The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from its correct position above the vibration feeder support plate and migrate to under the support plate. If this occurs, the uncapped sample tubes may hit the cable, and sample fluid (e.g., serum) may splash from the tube and into another tube or onto the under carriage of the support plate.
- RECALL
Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software Versions 2.2.1 through 2.8. If the user is utilizing User- Configured (Modified) parameters, ALL default settings are restored in the VITROS 5,1 FS Chemistry System from the ADD instead of retaining the user modified parameters.
- RECALL
Recapper Caps may fall off of, or be knocked from sample tubes placed in the storage racks of entry/exit modules. The gripper may grab a tube at the wrong height and drop the tube in the Rack Entry/Exit or Rack Exit module. These situations may result in splashing of bio-hazardous fluid. Sample cross-contamination may occur with an uncapped tube in the rack.
- RECALL
Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5.
- RECALL
Software anomaly: potential for delay in the reporting of patient sample test results when using enGen with TCAutomation Software v2.6 , v3.2 and v3.5 Configured with Bypass Modules for ADVIA Centaur, Abbott Architect, VITROS and/or Tosoh AIA Systems.
- RECALL
Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (Storage) prior to the completion of the necessary pending action. A delay in patient test result(s) reporting could occur as operator is not alerted that results have not been produced and that further actions are required.
- RECALL
Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen Select V5.0 & enGen Custom v3.2.2 due to an anomaly that affects the autoverification feature and custom rules that depend upon data elements used by the referenced enGen Systems.
- RECALL
Ortho Clinical Diagnostics received complaints of centrifuge buckets disconnecting from their supports during centrifugation when using the Hettich Rotanta 46 RSC Robotic Centrifuges, Models 4815, 4816 and 4817, that may be configured with enGen(TM) Laboratory Automation Systems.
- RECALL
Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre)
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