MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-05-23 for HIV 1/2 STAT-PAK ULTRA FAST HIV 101 * manufactured by Chembio Diagnostic Sytems, Inc..
[21625249]
False negative hiv tests.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022046 |
| MDR Report Key | 335648 |
| Date Received | 2001-05-23 |
| Date of Report | 2001-05-08 |
| Date of Event | 2001-04-01 |
| Date Added to Maude | 2001-06-05 |
| 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 | HIV 1/2 STAT-PAK ULTRA FAST |
| Generic Name | IMMUNOLOGIC TEST FOR ANTIBODIES TO HIV 1 & 2 |
| Product Code | MWB |
| Date Received | 2001-05-23 |
| Model Number | HIV 101 |
| Catalog Number | * |
| Lot Number | HIV 032000/2 |
| ID Number | * |
| Device Expiration Date | 2001-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 324993 |
| Manufacturer | CHEMBIO DIAGNOSTIC SYTEMS, INC. |
| Manufacturer Address | 3661 HORSEBLOCK RD MEDFORD NY 11763 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-05-23 |