MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-06-04 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-90 manufactured by Abbott Laboratories.
[870202]
The account noticed increased reactive rates for hiv-1/2 eia assay with reagent lot 62241m01. The account stated that in the past 30 days, more than 30 donors tested repeatedly hiv-1/2 eia reactive, but non-confirming by hiv-1 western blot and hiv-2. No specific data on the donors were provided. The account switched to a different hiv-1/2 eia reagent lot with acceptable reactive rates. Additionally, abbott field svc was requested to proactively inspect the commander ppc analyzer for the increase in reactive rates. No impact to pt management was reported.
Patient Sequence No: 1, Text Type: D, B5
[8023067]
(investigation is in process and no eval/conclusion codes are known at this time). 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 | 1415939-2008-00078 |
| MDR Report Key | 1056638 |
| Report Source | 05 |
| Date Received | 2008-06-04 |
| Date of Report | 2008-05-14 |
| Date of Event | 2008-05-14 |
| Date Mfgr Received | 2008-05-14 |
| Date Added to Maude | 2008-09-30 |
| 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, D-3MQC, AP6B |
| Manufacturer Street | 100 ABBOT PARK RD |
| 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 AN II |
| Product Code | LRM |
| Date Received | 2008-06-04 |
| Model Number | NA |
| Catalog Number | 3A77-90 |
| Lot Number | 62241M101 |
| ID Number | NA |
| 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 | 1072738 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-04 |