MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-03-06 for BECTON DICKINSON JIARDIA CRYPTOSPORIDIAM * manufactured by Becton Dickinson.
[18833231]
False test results on multiple pts. False positive cryptosporidium. Device is on recall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024268 |
| MDR Report Key | 380713 |
| Date Received | 2002-03-06 |
| Date of Report | 2002-03-06 |
| Date Added to Maude | 2002-03-12 |
| 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 | BECTON DICKINSON JIARDIA CRYPTOSPORIDIAM |
| Generic Name | COLOR PACK RAPID ASSAY |
| Product Code | MHJ |
| Date Received | 2002-03-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 219370 |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 369763 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-03-06 |