MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-30 for AKERS RAPID HIT AB PIFA TEST manufactured by Akers Bioscience, Inc..
[146902601]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5087059 |
| MDR Report Key | 8659260 |
| 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 RAPID HIT AB PIFA TEST |
| Generic Name | PLATELET FACTOR 4 RADIO IMMUNOASSAY |
| 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 BIOSCIENCE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2019-05-30 |