MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2008-01-23 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-90 manufactured by Abbott Laboratories.
[814132]
The customer stated there had been 8 quality control failures for hiv 1/2 (rdna) eia on the commander ppc over a 10 day time period. Positive control 1 and positive control 2 had been out of range low and the negative control had been aberrant. Technicians observed no color in the positive controls when opd was added. Upon repeat, quality control results would be in range. There was no report of incorrect pt results or impact to pt management.
Patient Sequence No: 1, Text Type: D, B5
[7936184]
This is an initial report. An investigation is in process. A final report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[18492974]
The company was informed that the pt underwent surgery for pe tube placement in 2009. Advanced bionics is in the process of gathering more info. Once more info becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[18596036]
(b)(4) an investigation was completed and identified that the bead component of the assay is linked to the controls out of range issue. In order to mitigate this issue, additional modes of control in the manufacturing process are being evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2008-00009 |
| MDR Report Key | 983495 |
| Report Source | 04,07 |
| Date Received | 2008-01-23 |
| Date of Report | 2007-12-27 |
| Date of Event | 2007-12-04 |
| Date Mfgr Received | 2009-12-17 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2010-01-14 |
| 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. NOEMI KONDOS RN, BSN |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 09B9, AP50 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 8479375120 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| 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 | IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF HIV-1 AND HIV-2 ANTIBODIES |
| Product Code | LRM |
| Date Received | 2008-01-23 |
| Model Number | NA |
| Catalog Number | 3A77-90 |
| Lot Number | 56099M201 |
| ID Number | NA |
| Device Expiration Date | 2008-01-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-23 |