COAGUCHEK ® XS SYSTEM Adverse Event — Malfunction (MDR 1823260-2020-01112)
COAGUCHEK ® XS SYSTEM Adverse Event — Malfunction (MDR 1823260-2020-01112) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: COAGUCHEK ® XS SYSTEM; Generic name: PROTHROMBIN TIME TEST STRIPS; Manufacturer: ROCHE DIAGNOSTICS.
| Device | COAGUCHEK ® XS SYSTEM |
|---|---|
| Generic name | PROTHROMBIN TIME TEST STRIPS |
| Manufacturer | ROCHE DIAGNOSTICS |
| Report number | 1823260-2020-01112 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | THE REPORTER'S PRODUCT WAS REQUESTED FOR INVESTIGATION AND REPLACEMENT PRODUCT WAS SENT TO THE REPORTER. THE PRODUCT HAS NOT BEEN RECEIVED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, A FOLLOW UP REPORT WILL BE SUBMITTED. ROUTINE RETENTION TESTING IS PERFORMED. RETENTION TESTING DATA IS REVIEWED AND APPROPRIATE ACTIONS ARE TAKEN AS NEEDED.COAGUCHEK USES HUMAN RECOMBINANT THROMBOPLASTIN. |
| Source | openFDA MAUDE (device adverse events) |
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