Roche CoaguChek XS Plus
Roche · Model CoaguChek XS Plus
Accurate, precise results in about one minute. The only system to perform onboard quality control and patient tests in a single test chamber. Results unaffected by heparin at therapeutic levels. INR corrected for hematocrit within specified range. Stores 2000 patient and 500 QC test results. Operator and QC lockout to ensure your policies are followed. Calibration via code chip. Stores lot data for up to 60 codes.
Typical Failure Modes
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
INR result out of expected range / QC failure
HighSymptoms: INR does not match the clinical picture or a lab draw, on-board or liquid QC fails.
Root cause: Expired or heat-damaged strips, a wrong-technique sample (too small / too slow / air), or use outside the operating temperature range.
Error code during a test
MediumSymptoms: Numbered error (e.g. strip / temperature / timing errors) on the display, result suppressed.
Root cause: A specific condition indexed in the meter's error-code list - strip, sample, temperature, or a meter fault.
Strip not detected / will not start
MediumSymptoms: Meter does not recognise the test strip or the code chip.
Root cause: Contaminated strip-guide contacts, a wrong / missing code chip, or a damaged strip.
Battery / power fault
MediumSymptoms: Short battery life, will not power on, will not charge (INRange).
Root cause: Depleted or aged battery.
Data transfer / connectivity fault (XS Plus / INRange)
LowSymptoms: Results will not download / sync via cable, Bluetooth or the base unit.
Root cause: Cable / port, Bluetooth pairing, or the docking base.
Serviceable Parts & Consumables
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
Test strips and code chip
Store per the insert; heat damages them.
Class Frequent wear itemRel. cost $$R&R Easy
Liquid QC controls
Class Frequent wear itemRel. cost $$R&R Easy
Battery / rechargeable pack
Class Frequent wear itemRel. cost $R&R Easy
Strip-guide / contact assembly
Class Periodic replacementRel. cost $$R&R Moderate
Docking base / cable (XS Plus / INRange)
Class Periodic replacementRel. cost $$R&R Easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Test strips and code chip Store per the insert; heat damages them. | Frequent wear item | $$ | Easy |
| Liquid QC controls | Frequent wear item | $$ | Easy |
| Battery / rechargeable pack | Frequent wear item | $ | Easy |
| Strip-guide / contact assembly | Periodic replacement | $$ | Moderate |
| Docking base / cable (XS Plus / INRange) | Periodic replacement | $$ | Easy |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
Troubleshooting Approach
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Symptom: INR result questionable / QC fails
- Repeat with a new strip from a correctly stored, in-date vial and a fresh fingerstick applied within seconds.
- Run the liquid QC at the expected level.
- Confirm the code chip matches the strip lot.
- Check the operating temperature.
- If QC fails with good strips, quarantine the lot; if it passes but patient INR still disagrees with the lab, refer the meter.
Symptom: Error code / strip not detected
- Note the error code and look it up in the meter's user guide.
- Clean the strip-guide contacts.
- Fit the correct code chip.
- Retry with a fresh strip.
- Contact Roche if the code persists.
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
- RECALL
Abnormally high INR test results with the affected CoaguChek test strips
- RECALL
Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.
- RECALL
The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
- RECALL
The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
- RECALL
Erroneous Test Results: Monitor may display 'error' message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.
- RECALL
If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.
- RECALL
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
- RECALL
Lack of assurance of sterility.
- RECALL
Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.
- RECALL
High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.
- RECALL
Discrepancy between INR and the % Quick displayed on the meter.
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