MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-11-27 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-69 manufactured by Abbott Laboratories.
[770525]
The account generated a reactive hiv-1/2 eia result on a specimen that tested negative with confirmatory testing. The specimen tested repeatedly hiv-1/2 eia >2. 0 s/co but rapid hiv test negative, western blot negative and hiv-2 negative. No pt info or history was provided. No impact to pt mgmt was reported.
Patient Sequence No: 1, Text Type: D, B5
[8039223]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete. Investigation has not started.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2007-00258 |
| MDR Report Key | 953910 |
| Report Source | 05 |
| Date Received | 2007-11-27 |
| Date of Report | 2007-10-29 |
| Date of Event | 2007-10-29 |
| Date Mfgr Received | 2007-10-29 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2008-03-10 |
| 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 | DR DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479379328 |
| 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 | 2007-11-27 |
| Model Number | NA |
| Catalog Number | 3A77-69 |
| Lot Number | 54853M100 |
| ID Number | NA |
| Device Expiration Date | 2007-10-28 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 950809 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-27 |