MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-20 for COAGUCHEK ? XS SYSTEM 03666794001 manufactured by Roche Diagnostics.
[184302851]
The customer? S meter was requested for return. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[184302852]
The initial reporter complained of a burning or charring issue with coaguchek xs meter serial number (b)(4). The customer complained of various error messages (example: error 4) and was unable to perform a test. It was noted that the heater plate appeared to be charred or burnt. There were no other signs of burning, melting, or smoking to any other portion of the meter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2020-00793 |
| MDR Report Key | 9860755 |
| Report Source | CONSUMER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COAGUCHEK ? XS SYSTEM |
| Generic Name | PROTHROMBIN TIME MONITOR |
| Product Code | GJS |
| Date Received | 2020-03-20 |
| Model Number | NA |
| Catalog Number | 03666794001 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |