MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2007-11-16 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-69 manufactured by Abbott Laboratories.
[740240]
In 2007, abbott laboratories became aware of a media report that stated four transplant recipients contracted hiv and hcv from an organ donor. It was confirmed by gift of hope organ and tissue donation center that abbott's hiv 1-2 (rdna) eia and hcv eia 2. 0 kits were used to test the donor sample in early 2007 and test results were nonreactive. After the recipients' infections were identified, gift of hope sent the donor's serum to a commercial laboratory for retesting. The retest was reported to be elisa negative for hiv and hcv (method not known), confirming the abbott results. Further naat testing identified and hiv and hcv infection that the earlier tests had not identified, suggesting that the donor was infected, but had not yet produced the antibodies that the elisa test is designed to detect. According to media reports, officials at gift of hope stated that a screening questionnaire determined that the organ had engaged in high risk behavior. From the data reported, the abbott assay performed correctly and the abbott results were confirmed by the commercial laboratory.
Patient Sequence No: 1, Text Type: D, B5
[8121415]
The reagent kit and donor sample were not returned for investigation. The reagent kit expired in 2007. This is an initial report. An investigation is in process. A final report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2007-00253 |
| MDR Report Key | 948357 |
| Report Source | 00,07 |
| Date Received | 2007-11-16 |
| Date of Report | 2007-11-13 |
| Date of Event | 2007-01-15 |
| Date Mfgr Received | 2007-11-13 |
| Date Added to Maude | 2007-11-21 |
| 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 | 2007-11-16 |
| Model Number | NA |
| Catalog Number | 3A77-69 |
| Lot Number | 45395M200 |
| ID Number | NA |
| Device Expiration Date | 2007-02-21 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 921564 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2007-11-16 |