MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for EPOC BGEM BUN TEST CARD 10736515 manufactured by Epocal Inc..
[146067489]
The single blood analysis test card was inserted into the epoc blood analysis system. The system went through its initialization process then had an error statement: "fluid in card. " there was no fluid introduced or in the area of the card. The card was removed from the foil wrap and inserted into the reader. There was no significant temperature change to create moisture. A second blood analysis test card was used (same lot number) with success. Ambulance team to continue to monitor for failures/issues with the blood analysis test cards.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8640061 |
| MDR Report Key | 8640061 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-05-07 |
| Report Date | 2019-05-15 |
| Date Reported to FDA | 2019-05-15 |
| Date Reported to Mfgr | 2019-05-24 |
| Date Added to Maude | 2019-05-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | EPOC BGEM BUN TEST CARD |
| Generic Name | ELECTRODE, ION SPECIFIC, UREA NITROGEN |
| Product Code | CDS |
| Date Received | 2019-05-24 |
| Model Number | 10736515 |
| Catalog Number | 10736515 |
| Lot Number | 10-19025-20 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EPOCAL INC. |
| Manufacturer Address | 2 EDGEWATER DRIVE NORWOOD MA 02062 US 02062 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-24 |