MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-12-20 for MUREX WELLCOGEN BACTERIAL ANTIGEN KIT * 30859602 -REMEL- manufactured by Murex Diagnostics Distributed By Remel, Inc..
[220770]
State dept of health sent proficiency test specimens to lab holding a state lab permit. A total of 84 labs tested a simulated csf specimen containing group b streptococcus using antigen detection kits. Eight labs were unable to detect the presence of group b strep and all of these eight labs used the murex wellcogen bacterial antigen kit. Five of the eight used the same lot number. 38 labs did detect the presence of this antigen using the murex wellcogen kit. Lot number info is unk. Remel, the distributor of this kit, has been contacted by rptr and by clinical labs which used the kit and obtained an incorrect result. An investigation is ongoing. Rptr has provided them with samples of proficiency test specimen and they have requested that the kit be returned by at least one clinical lab so that they can evaluate it against rptr's samples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023689 |
| MDR Report Key | 369039 |
| Date Received | 2001-12-20 |
| Date of Report | 2001-12-20 |
| Date of Event | 2001-09-25 |
| Date Added to Maude | 2002-01-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MUREX WELLCOGEN BACTERIAL ANTIGEN KIT |
| Generic Name | DIRECT ANTIGEN TEST |
| Product Code | GTZ |
| Date Received | 2001-12-20 |
| Model Number | * |
| Catalog Number | 30859602 -REMEL- |
| Lot Number | KIT: H324310 |
| ID Number | STREP B LATEX: H322710 |
| Device Expiration Date | 2002-05-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 358154 |
| Manufacturer | MUREX DIAGNOSTICS DISTRIBUTED BY REMEL, INC. |
| Manufacturer Address | * LENEXA KS * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-12-20 |