MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-05-08 for DPC IMMULITE H PYLORI IGG * manufactured by Diagnostic Products Corp.
[189194]
False positive serologic results for helicobacter pylori igg. Mfr indicates other lots affected for another instrument (immulite 2000).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021839 |
| MDR Report Key | 331692 |
| Date Received | 2001-05-08 |
| Date of Report | 2001-05-01 |
| Date of Event | 2000-10-01 |
| Date Added to Maude | 2001-05-14 |
| 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 |
| 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 | DPC IMMULITE H PYLORI IGG |
| Generic Name | DIAGNOSTIC KITS |
| Product Code | KTO |
| Date Received | 2001-05-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 321059 |
| Manufacturer | DIAGNOSTIC PRODUCTS CORP |
| Manufacturer Address | 5700 W 96TH ST LOS ANGELES CA 900455597 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-05-08 |