MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for BIOKIT HSV-2 RAPID TEST 3000 28001 manufactured by Biokit, Sa.
[179382414]
Twenty-one blood samples that were (b)(6) for (b)(6) on the diasorin liaison hsv test were submitted to (b)(6) for bio kit test. Six of the samples were biokit (b)(6): the 6 biokit (b)(6) samples were sent for western blot test 4 were wb (b)(6) for (b)(6). I was wb (b)(6) for (b)(6) was wb indeterminate for (b)(6). (b)(6) rate for biokit compared to western blot (run at university of (b)(6)) was 66%. The 6 biokit samples were run at (b)(6). Diasorin liaison is an fda-cleared screening test for (b)(6) by immunoassay. Western blot is the gold standard for confirmation and was run at the university of (b)(6) urology lab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092892 |
| MDR Report Key | 9693750 |
| Date Received | 2020-02-10 |
| Date Added to Maude | 2020-02-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 | 3 |
| Brand Name | BIOKIT HSV-2 RAPID TEST |
| Generic Name | ENZYME LINKED IMMUNOABSORBENT ASSAY, HERPES SIMPLEX VIRUS, NON-SPECIFIC |
| Product Code | LGC |
| Date Received | 2020-02-10 |
| Model Number | 3000 28001 |
| Lot Number | B31915 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOKIT, SA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |