MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-04-03 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-68 manufactured by Abbott Laboratories.
[826127]
A physician questioned a repeat reactive result on abbott hivab hiv-1/hiv-2 (rdna) eia on a patient that had no risk factors. The sample was sent to another laboratory for confirmation and was negative on western blot and for hiv-2. A second sample was obtained from this patient and sent to another laboratory where a negative result was obtained on genetic systems hiv 1/2 eia. The sample was tested on hivab hiv 1/2 (rdna) eia and generated an initial reactive result. No impact to patient management was reported.
Patient Sequence No: 1, Text Type: D, B5
[8025345]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2008-00044 |
| MDR Report Key | 1024313 |
| Report Source | 04 |
| Date Received | 2008-04-03 |
| Date of Report | 2008-03-07 |
| Date of Event | 2008-03-07 |
| Date Mfgr Received | 2008-03-07 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2008-09-12 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUDARSHAN HEBBAR, MD |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479379677 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIVAB HIV-1/HIV-2 (RDNA) EIA |
| Generic Name | EIA FOR DETECTION OF AB TO HIV I AND II |
| Product Code | LRM |
| Date Received | 2008-04-03 |
| Model Number | NA |
| Catalog Number | 3A77-68 |
| Lot Number | 59195M100 |
| ID Number | NA |
| Device Expiration Date | 2008-03-05 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1021610 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-03 |