MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-23 for WELCOGEN STREP B TEST LATEX FOR URINE RAPID SCREENS ZL20 manufactured by Murex Diagnostics, Inc..
[16539]
While testing pt determined that the test latex for urine rapid screens was not reacting properly. The controls did not react in the correct manner. Further investigation revealed that 2 incorrect positive strep b urine rapid screen results had been reported 2/28/96 on a second and third pt. Repeat testing 3/3 for the second pt showed negative results with another lot number. Results were corrected and the nurse was notified of problem. The third patient had already been discharged by 3/3. The pt was called back and repeat testing was performed 3/6/96. Repeat testing and results were corrected. Add'l date of event 3/3/96.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008725 |
| MDR Report Key | 31573 |
| Date Received | 1996-03-27 |
| Date of Report | 1996-03-06 |
| Date of Event | 1996-02-28 |
| Date Added to Maude | 1996-04-02 |
| 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 |
| 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 | WELCOGEN STREP B TEST LATEX FOR URINE RAPID SCREENS |
| Generic Name | STREP B TEST LATEX FOR URINE RAPID SCREENS |
| Product Code | GTY |
| Date Received | 1996-04-23 |
| Catalog Number | ZL20 |
| Lot Number | K934910 |
| Device Expiration Date | 1996-11-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32713 |
| Manufacturer | MUREX DIAGNOSTICS, INC. |
| Manufacturer Address | 3075 NORTHWOODS CIRCLE NORCROSS GA 30071 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-03-27 |