MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-02-28 for HIVAB HIV-1/HIV-2(RDNA) EIA 3A77-68 manufactured by Abbott Laboratories.
[16367602]
The customer stated a patient who was transferred to their facility to be evaluated for a possible liver transplant tested repeat reactive on the abbott hiv 1-2 (rdna) eia but was negative on other methods. The patient was seen in an emergency room, admitted to an outside hospital and then transferred to another clinics in 2008. The patient tested hiv negative on the next day using the medmira rapid hiv1 assay. Two days later, an initial reactive result was generated on the abbott hiv 1-2 (rdna) eia and upon retesting in duplicate on the following day, both results were reactive. The patient was removed from the transplant registry due to the repeat reactive results. The patient tested below the limit of detection on hiv1 pcr and was negative on western blot hiv1 and on a hiv2 specific elisa test. The patient expired 3 days later.
Patient Sequence No: 1, Text Type: D, B5
[16487070]
This is an initial report. Patient sample has been requested for return. 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 | 1415939-2008-00036 |
| MDR Report Key | 1004259 |
| Report Source | 05,07 |
| Date Received | 2008-02-28 |
| Date of Report | 2008-02-22 |
| Date of Event | 2008-02-18 |
| Date Mfgr Received | 2008-02-22 |
| Date Added to Maude | 2008-03-05 |
| 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 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 | 2008-02-28 |
| Model Number | NA |
| Catalog Number | 3A77-68 |
| Lot Number | 59546M100 |
| ID Number | NA |
| Device Expiration Date | 2008-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 973975 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 600643500 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-02-28 |