MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-25 for GAP IGG HELICOBACTER PYLORI * 404 2050 manufactured by Biomerica Inc..
[170179]
Various dates in late august and early september, 2000. Pts tested with different batches (lot) of h. Pylori eia are negative or positive depending upon the batch (lot) of kit used. Vendor says this lot-to-lot variability is expected. Cannot rely on test for lab data.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020014 |
| MDR Report Key | 297982 |
| Date Received | 2000-09-25 |
| Date of Report | 2000-09-25 |
| Date of Event | 2000-09-09 |
| Date Added to Maude | 2000-09-29 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAP IGG HELICOBACTER PYLORI |
| Generic Name | IN VITRO DIAGNOSTIC TEST |
| Product Code | KTO |
| Date Received | 2000-09-25 |
| Model Number | * |
| Catalog Number | 404 2050 |
| Lot Number | 0427276-1 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 288435 |
| Manufacturer | BIOMERICA INC. |
| Manufacturer Address | 1533 MONROVIA AVE. NEWPORT BEACH CA 92663 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-09-25 |