MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-05-08 for HIVAB HIV-1/HIV-2(RDNA)EIA 3A77-78 manufactured by Abbott Laboratories.
[646143]
The account generated a negative hiv-1/2 eia result on a pt that tested hiv reactive at another laboratory. The account was acting as a reference laboratory for a customer that aliquoted specimens to send a two reference laboratories. The account generated a negative hiv-1/2 eia result (0. 097 od value, cutoff=0. 120) on specimen id which tested hiv reactive at another lab. A second specimen id from the same pt donation was again sent to the account and the other lab. The account generated reactive hiv -a/2 eia results (0. 153, 0. 155 od values, cutoff =0. 116) and the other lab generated reactive hiv results. The account sent specimen id for add'l testing. The sample tested western blot indeterminate and hiv-2 reactive (0. 188, 0. 195 od values, cutoff=0. 1880). The account processed the specimens using the commander fpc, commander ppc and dynamic incubator. The negative hiv-1/2 eia result was reported outside of the lab and questioned by medical practioner. No impact to pt management was reported. End of report.
Patient Sequence No: 1, Text Type: D, B5
[7966011]
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 | 1415939-2007-00029 |
| MDR Report Key | 851360 |
| Report Source | 05 |
| Date Received | 2007-05-08 |
| Date of Report | 2007-04-12 |
| Date of Event | 2007-02-01 |
| Date Mfgr Received | 2007-04-12 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2007-05-30 |
| 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 | DR DAVID BARCH, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK RD. |
| Manufacturer City | ABBOTT PARK IL 600643500 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643500 |
| Manufacturer Phone | 8479379328 |
| Manufacturer City | IL |
| Manufacturer Country | US |
| 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 | 2007-05-08 |
| Model Number | NA |
| Catalog Number | 3A77-78 |
| Lot Number | 48035M200 |
| ID Number | NA |
| Device Expiration Date | 2007-04-18 |
| 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 | 838564 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-08 |