MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-28 for EMIT II PLUS AMPHETAMINESS ASSAY -SYVA REAGENTS * manufactured by Dade Behring.
[15443751]
Dade-behring provides incorrect "curve-fit" instructions to technical service representatives & customers for semi quantative amphetamines determination. Resulted in a failure of a state proficiency test sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034211 |
| MDR Report Key | 565287 |
| Date Received | 2004-12-28 |
| Date Added to Maude | 2005-01-14 |
| 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 | 3 |
| 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 | EMIT II PLUS AMPHETAMINESS ASSAY -SYVA REAGENTS |
| Generic Name | OLYMPUS AV/5200 |
| Product Code | DKZ |
| Date Received | 2004-12-28 |
| Model Number | NA |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 555058 |
| Manufacturer | DADE BEHRING |
| Manufacturer Address | * BROOKFIELD CT * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-12-28 |