MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-05-10 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-28 manufactured by Abbott Laboratories.
[16795570]
The account generated and reported a negative hiv 1-2 (rdna) eia pt result. The result was questioned by he physician since this pt had previously tested positive for hiv. A new sample from this pt was tested on hiv 1-2 (rda)eia and reactive results were generated and confirmed positive on western blot. The account pipets manually and believes the pt sample may not have been pipetted into the reaction tray well since this was the only sample taht produced a negative absorbance value. No impact to pt management was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1415939-2005-00011 |
| MDR Report Key | 601632 |
| Report Source | 06 |
| Date Received | 2005-05-10 |
| Date of Report | 2005-05-10 |
| Date Mfgr Received | 2005-04-12 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2005-05-13 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR. DAVID SPINDELL, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479351869 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2005-05-10 |
| Model Number | NA |
| Catalog Number | 3A77-28 |
| Lot Number | 25144M200 |
| ID Number | NA |
| Device Expiration Date | 2005-06-01 |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 591452 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK RD. ABBOTT PARK IL 600643500 US |
| Baseline Brand Name | HIVAB HIV-1/HIV-2 (RDNA) EIA |
| Baseline Generic Name | EIA FOR DETECTION OF AB TO HIV I AND II |
| Baseline Model No | NA |
| Baseline Catalog No | 3A77-28 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-05-10 |