MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-30 for AKERS BIOSCIENCES RAPID PIFA HIT ALO TESTING manufactured by Akers Biosciences, Inc..
[146902505]
Akers bioscience pifa anti pf4 hit antibody testing came back negative, which delayed the diagnosis of the rare spontaneous hit, repeat was alos negative, but later hit elisa and sra was positive. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5087039 |
| MDR Report Key | 8658542 |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-27 |
| Date Added to Maude | 2019-05-31 |
| 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 | AKERS BIOSCIENCES RAPID PIFA HIT ALO TESTING |
| Generic Name | PLATELET FACTOR 4 RADIOIMMUNOASSAY |
| Product Code | LCO |
| Date Received | 2019-05-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AKERS BIOSCIENCES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-05-30 |