MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-03 for QUANTTTEST RED * 5210-12 manufactured by Quantimetrix.
[17171899]
The quanttest red total protein assay system kit marketed by quantimetrix and being used to measure urine proteins does not measure light chains and therefore gives an inaccurate measure of urinary protein in pts with light chain proteinuria. The mfr acknowledges this problem, but there is no indication in the product literature of this problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026346 |
| MDR Report Key | 420464 |
| Date Received | 2002-10-03 |
| Date of Report | 2002-10-03 |
| Date Added to Maude | 2002-10-08 |
| 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 | QUANTTTEST RED |
| Generic Name | LABORATORY TEST KIT |
| Product Code | CEK |
| Date Received | 2002-10-03 |
| Model Number | * |
| Catalog Number | 5210-12 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 409520 |
| Manufacturer | QUANTIMETRIX |
| Manufacturer Address | 2005 MANHATTAN BEACH BLVD REDONDO BEACH CA 902781205 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-10-03 |