MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-27 for ALEXON-TREND * 540-9C, 540-24 manufactured by Alexon-trend.
[135095]
Diagnostic assay for cryptosporidium infection is producing false-positive results. Resulted in reporting about 40 pts with false-positives since 10/97.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 160307 |
| MDR Report Key | 160307 |
| Date Received | 1998-03-27 |
| Date Facility Aware | 1998-03-25 |
| Report Date | 1998-03-27 |
| Date Added to Maude | 1998-04-03 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALEXON-TREND |
| Generic Name | CRYPTOSPORIDIUM MICROPLATE ASSAY |
| Product Code | MHJ |
| Date Received | 1998-03-27 |
| Model Number | * |
| Catalog Number | 540-9C, 540-24 |
| Lot Number | 980402,980808,975006,(MORE) |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 156117 |
| Manufacturer | ALEXON-TREND |
| Manufacturer Address | 14000 UNITY ST., NW RAMSEY MN 55303 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-03-27 |