D
Patient 1
HIT AB TESTING DONE USING AKERS BIO SCIENCE HIT AB TEST WAS NEGATIVE, WHICH DELAYED THE DIAGNOSIS OF HIT AND HIT ELISA AB SENT OUT SIDE CAME BACK POSITIVE ALONG WITH SRA TESTING. FDA SAFETY REPORT ID # (B)(4).
MAUDE MDR 8659260
- MDR report key
- 8659260
- Report number
- MW5087059
- Event key
- 0
- Event type
- 3
- Date received
- 2019-05-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- P
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AKERS RAPID HIT AB PIFA TEST | PLATELET FACTOR 4 RADIO IMMUNOASSAY | AKERS BIOSCIENCE, INC. | LCO | I | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-05-30 | 0 | 1. L; 2. S |