MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-11-13 for ORAQUICK ADVANCE * manufactured by Orasure Technologies.
[21695962]
Oraquick advance hiv test appeared to be positive. After being informed of the result the counselor said she would send the test to the ohio dept of health for confirmation. After a lot of crying and emotional turmoil and at the request of a family member the test was repeated with an oraquck testing device and it was negative but the original test and an orasure are being sent for confirmation. If the counselor had originally taken the second test device from the drawer, there would not have been a problem. A positive hiv test is a life-altering event and nobody should be subjected to a false test result whether negative or positive. What if the device is defective and others have been given a clean bill of health and are actually positive for hiv. What is the point of getting quick test results if the results are not accurate? I want info on how many cases of false-negatives have been reported since this test came into use. One is too many when it strikes too close to home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040959 |
| MDR Report Key | 781253 |
| Date Received | 2006-11-13 |
| Date of Report | 2006-11-13 |
| Date of Event | 2006-11-10 |
| Date Added to Maude | 2006-11-16 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORAQUICK ADVANCE |
| Generic Name | * |
| Product Code | MTL |
| Date Received | 2006-11-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 769033 |
| Manufacturer | ORASURE TECHNOLOGIES |
| Manufacturer Address | * BETHLEHEM PA 18015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-11-13 |