MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-12-06 for GENETIC SYSTEMS RLAV EIA 32511 manufactured by Bio-rad Laboratories.
[776061]
Bio-rad laboratories technical support received a call in 2007 regarding 2 non reactive pt results while running the genetic systems rlav eia test kit using a 4 plate system called the evolis. Pt #1 was informed of the non reactive result. The second pt had already left before being informed of his results. Their blood work had previously been tested at the state lab where the results were positive. Pt #1 was redrawn and retested, and the result from this retest was positive. Bio-rad laboratories technical support requested that a sample from the individual be sent to bio-rad laboratories product support for testing. The customer stated that since pt #2 is no longer there, authorities are attempting to locate him to request he come in for retesting. However, the retesting of this individual would be done at the state lab so she would not have access to these results. The evolis instrument is used for pipetting of samples and reagents, and performing functions necessary to complete processing of microplate assays. With each pt sample tube, the customer receives 3x5 cards with the pt name, accession number and list of tests requested. The 3x5 cards are placed in the same order as the specimen tubes and used to manually enter the accession numbers and the requested tests into the evolis instrument. Customer stated that the 2 false negative samples were not run on the same plate. Testing performed by bio-rad laboratories product support on 5 lot numbers of the genetic system rlav eia assay and gs hiv-1 western blot, as well as testing performed on the evolis instrument, indicates a possibility that the 2 false negative results are due to a sample mix-up. Bio-rad laboratories' conclusion is that the customer's current practice of manually entering the pt id number, instead of using a barcode system, as recommended by bio-rad laboratories, lead to a sample mix-up and resulted in the false negative results.
Patient Sequence No: 1, Text Type: D, B5
[8010904]
Conclusions: the assays were valid per the package insert criteria across each of the kit lots tested. Sample tested reactive in duplicate on all five lots of rlav eia and positive on hiv-1 western blot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3022521-2007-00004 |
| MDR Report Key | 960531 |
| Report Source | 05 |
| Date Received | 2007-12-06 |
| Date of Report | 2007-12-06 |
| Date of Event | 2007-11-07 |
| Date Mfgr Received | 2007-11-07 |
| Device Manufacturer Date | 2007-07-05 |
| Date Added to Maude | 2008-05-20 |
| 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 | CHRISTOPHER BENTSEN |
| Manufacturer Street | 6565 185TH AVE., N.E. |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254981709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENETIC SYSTEMS RLAV EIA |
| Generic Name | IVD, EIA |
| Product Code | LRM |
| Date Received | 2007-12-06 |
| Catalog Number | 32511 |
| Lot Number | 170BAA-05 |
| Device Expiration Date | 2008-05-08 |
| 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 | 968406 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 6565 185TH AVE., N.E. REDMOND WA 98052 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-06 |