MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-06-24 for HIVAB-HIV-1/HIV-2 (RDNA) EIA 3A77-28 manufactured by Abbott Laboratories.
[509358]
When using hivab hiv-1/hiv-2 (rdna) eia, the customer obtained an initial reactive result (absorbance >2. 000) on a patient sample. Upon duplicate repeat testing, negative results (absorbances -0. 002 and -0. 003) were obtained and reported. A satelite facility, that forwarded the patient sample to the customer for supplemental testing, had obtained hiv 1/2 reactive results. Additionally, the patient is hiv-1 positive based on previous testing and is being treated for hiv at an aids clinic. Western blot testing was performed on the patient sample and was positive. Upon retesting the patient sample, the customer obtained repeatedly reactive results.
Patient Sequence No: 1, Text Type: D, B5
[7846841]
Abbott did not perform any testing since the customer believes that conjugate inadvertently did not get added to the two replicates that produced non-reactive results. A procedural error was identified as the cause of the non-reactive results that were obtained at the customer's facility and no further investigation was necessary. This issue is addressed in the hivab hiv-1/hiv-2 (rdna) eia package insert (commodity 68-0158/r12). Refer to assay procedure, second incubation, step 8. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2005-00021 |
| MDR Report Key | 744670 |
| Report Source | 06 |
| Date Received | 2005-06-24 |
| Date of Report | 2005-06-24 |
| Date of Event | 2005-05-30 |
| Date Mfgr Received | 2005-06-01 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2006-08-08 |
| 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 1 AND 11 |
| Product Code | LRM |
| Date Received | 2005-06-24 |
| Model Number | NA |
| Catalog Number | 3A77-28 |
| Lot Number | 27109M200 |
| ID Number | NA |
| Device Expiration Date | 2005-08-01 |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 732477 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD 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 | 2005-06-24 |