MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-24 for EQUAL -GENZYME- DIRECT LDL REAGENT ON DADE DIMENSION RXL * manufactured by Genzyme.
[17105792]
Direct ldl cholesterol performed on dade dimension produces erratic results. Distributor aware of this with another user. Did not inform clients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023212 |
| MDR Report Key | 358355 |
| Date Received | 2001-10-24 |
| Date of Report | 2001-10-24 |
| Date Added to Maude | 2001-10-31 |
| 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 | EQUAL -GENZYME- DIRECT LDL REAGENT ON DADE DIMENSION RXL |
| Generic Name | LABORATORY DIAGNOSTIC REAGENT |
| Product Code | LBS |
| Date Received | 2001-10-24 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 347550 |
| Manufacturer | GENZYME |
| Manufacturer Address | * CAMBRIDGE MA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-10-24 |