
Roche · Model CoaguChek XS Pro
Barcode reader for faster ID entry. Time critical INR results - faster than sending them to the lab. Electronic data capture and transmission aid compliance with accreditation and regulatory standards such as JCI and CLIA '88.
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.
Symptoms: The laboratory & diagnostics is dead, reboots, or shuts down mid-use.
Root cause: Mains lead / fuse, an aged battery, or a power-supply board fault.
Symptoms: Short run time on battery; low-battery alarm soon after a full charge.
Root cause: Aged rechargeable battery pack or a charger fault.
Symptoms: Blank, dim or distorted display; unresponsive keys or touchscreen.
Root cause: Display, backlight, or control-board fault.
Symptoms: Power-on self-test or the scheduled performance check fails or is out of tolerance.
Root cause: Sensor drift or an internal board fault; recalibration or repair needed.
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.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Rechargeable battery pack | Periodic replacement | $$ | Fairly easy |
| Power supply / mains board | Major service part | $$$ | Difficult |
| Display / control-panel assembly | Major service part | $$$ | Moderate |
| Cooling fan | Major service part | $ | Moderate |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
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.
No documents available for this device yet.
Synced live from the FDA openFDA API.
Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results
Abnormally high INR test results with the affected CoaguChek test strips
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.
The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
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.
Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.
High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.
Discrepancy between INR and the % Quick displayed on the meter.
Describe a symptom or error code. Bio answers from this device's own documented error codes, failure modes, parts, and guides.
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