MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-04-24 for GENETIC SYSTEMS RLAV EIA * 32511 manufactured by Bio-rad Laboratories.
[456322]
Bio-rad laboratories technical support received a phone call from a customer. Customer stated that they performed a total of 3 runs using the genetic systems rlav eia (an hiv-1 antibody eia) assay along with external positive and negative controls manufactured by blackhawk biosystems inc. 2 of the runs showed the external positive control was negative and 1 run the external positive control was just above the cutoff. Previous to these runs the external positive control had been valid. Technical support requested that the customer fax their data for review. In investigating the issue with the customer, it was determined that the technicians were leaving multiple vials of conjugate concentrate of different lot numbers in their refrigerator and they were not necessarily using correct lot-specific vials when preparing the working conjugate for each run of the genetic systems rlav eia kit. The customer indicated that they have since corrected this practice. Page 6 of the genetic systems rlav eia package insert under precautions for users states: -#2 the only reagents that may be used with different lots of the rlav eia or other genetic systems test kits are the chromogen reagent, chromogen diluent, wash solution concentrate and stopping solution. Do not mix any other reagents from different lots.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3022521-2006-00002 |
| MDR Report Key | 704517 |
| Report Source | 05 |
| Date Received | 2006-04-24 |
| Date of Report | 2006-04-21 |
| Date of Event | 2006-03-24 |
| Date Mfgr Received | 2006-03-24 |
| Date Added to Maude | 2006-04-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTOPHER BENTSEN |
| Manufacturer Street | 6565 185TH AVENUE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254981709 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2006-04-24 |
| Model Number | * |
| Catalog Number | 32511 |
| Lot Number | 202YAA-05 |
| ID Number | * |
| Device Expiration Date | 2006-05-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 693602 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | * REDMOND WA 98052 US |
| Baseline Brand Name | GENETIC SYSTEMS RLAV EIA |
| Baseline Generic Name | IVD, EIA |
| Baseline Model No | * |
| Baseline Catalog No | 32511 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-24 |