MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1998-09-15 for HOME ACCESS HIV-1 TEST SYSTEM * 448550 manufactured by Home Access Health Corporation.
[82219]
Client tested negative with home access hiv-1 test system on 8/7/98. Client reported testing positive for hiv in 11/95. Client reported that he has been treated by a physician but the physician did not test him prior to treatment for hiv. Client refused to break anonymity or provide release to obtain medical records so previous test results could be verified. Review of hah lab results, (eia) verified negative. Unable to verify clients claim of previous positive test results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 59529-1998-90001 |
| MDR Report Key | 187335 |
| Report Source | 04 |
| Date Received | 1998-09-15 |
| Date of Report | 1998-09-09 |
| Date of Event | 1998-08-09 |
| Date Mfgr Received | 1998-08-09 |
| Device Manufacturer Date | 1998-03-01 |
| Date Added to Maude | 1998-09-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOME ACCESS HIV-1 TEST SYSTEM |
| Generic Name | HIV-1 ANTIBODY DETECTION SYSTEM |
| Product Code | DDQ |
| Date Received | 1998-09-15 |
| Model Number | * |
| Catalog Number | 448550 |
| Lot Number | 982104 |
| ID Number | * |
| Device Expiration Date | 2000-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 182087 |
| Manufacturer | HOME ACCESS HEALTH CORPORATION |
| Manufacturer Address | 2401 W. HASSELL SUITE 1510 HOFFMAN ESTATES IL 601955200 US |
| Baseline Brand Name | HOME ACCESS HIV-1 TEST SYSTEM |
| Baseline Generic Name | HIV-1 ANTIBODY DETECTION SYSTEM |
| Baseline Model No | * |
| Baseline Catalog No | 448550 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 3 | 1. Other | 1998-09-15 |