MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-01 for ORAQUICK * manufactured by Orasure Technologies, Inc..
[322122]
When using the oraquick, a rapid hiv-1 antibody test manufactured by orasure technologies. It is very, very difficult to read a positive test results. In the package insert it shows an example of a reactive test results. This example is very deceptive as the line noted is not as one see it. When doing their cap survey and running a positive control, the reactive line in actuality is very, very faint. So faint that experienced medical techs are hard press to read a known positive as positive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1028895 |
| MDR Report Key | 469848 |
| Date Received | 2003-07-01 |
| Date of Report | 2003-07-01 |
| Date of Event | 2003-07-01 |
| Date Added to Maude | 2003-07-08 |
| 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 | ORAQUICK |
| Generic Name | RAPID HIV1 ANTIBODY TEST |
| Product Code | MTL |
| Date Received | 2003-07-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 458715 |
| Manufacturer | ORASURE TECHNOLOGIES, INC. |
| Manufacturer Address | * BETHLEHEM PA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-01 |