MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-28 for VERIFYNOW manufactured by Werfen Company/accriva Diagnostic, Inc..
[131943516]
Th instrument is the verifynow manufactured by instrumentation laboratory/a werfen company. The device is used for determining a patient's response to plavix and aspirin. Over the past year we have reported numerous testing/instrument failures to il. We were notified today that there is a random issue with test cartridges where a? Faulty? Filter can allow blood to seep from the cartridge into the analyzer. They stated there is no impact to patient results, but we are convinced that this is accurate. They have offered to provide us with additional back up instruments at no cost until they are able to find resolution, but to date are not sending out any product recall or product alert.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082683 |
| MDR Report Key | 8206295 |
| Date Received | 2018-12-28 |
| Date of Report | 2018-12-27 |
| Date of Event | 2018-12-24 |
| Date Added to Maude | 2018-12-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VERIFYNOW |
| Generic Name | SYSTEM, AUTOMATED PLATELET AGGREGATION |
| Product Code | JOZ |
| Date Received | 2018-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WERFEN COMPANY/ACCRIVA DIAGNOSTIC, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-12-28 |