MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-17 for MERIDIAN CALAS CRYPTOCOCCAL ANTIGEN LATEX manufactured by .
[18618064]
The calas cryptococcal antigen latex agglutination system from meridian bioscience, inc. This kit lot number is 140108. 242. The pronase from this kit (lot # 1408. 169) did not perform with reproducible accuracy. Each kit comes with 2 vials of pronase from the same lot. One vial from this kit resulted in 4 positive serum cryptococcal antigens from 2 different pts. The second vial from the same kit resulted in 4 negative serum cryptococcal antigens from the same 2 pts using same serum samples. The pronase that resulted in positive results was checked for possible contamination. In a controlled experiment, the pronase was not contaminated with positive pt sample or positive control.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009511 |
| MDR Report Key | 1277356 |
| Date Received | 2008-12-17 |
| Date of Report | 2008-12-05 |
| Date of Event | 2008-11-26 |
| Date Added to Maude | 2009-01-16 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MERIDIAN CALAS CRYPTOCOCCAL ANTIGEN LATEX |
| Generic Name | AGGLUTINATION SYSTEM |
| Product Code | GMD |
| Date Received | 2008-12-17 |
| Lot Number | 140108.242 |
| Device Expiration Date | 2009-07-07 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-17 |