MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-04 for ROCHE/HITACHI TINA-QUANT ALBUMIN ASSAY ON MODULAR P 03576108 190 manufactured by Roche Diagnostics Corp.
[793344]
We have recently experienced several misleading results with the roche/hitachi tina-quant urine albumin assay on the modular p analyzer in which clinically significant. Proteinuria would have been missed. Initially, three errors were identified by comparison with prior pt results. We identified three more missed cases out of approximately 2100 samples analyzed over the weekend. These additional missed cases were identified by visual review of the reaction monitor tracing, followed by reanalysis after ten-fold dilution. Although there is a prozone detection algorithm on the system, and the detection threshold was made more sensitive raised to 1100 about a year ago, we suspect that the detection threshold must be made more sensitive raised to 1300. Although, we know of no patients who have been harmed by this assay problem, the risk is great that significant renal disease may be missed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005265 |
| MDR Report Key | 996356 |
| Date Received | 2008-02-04 |
| Date of Report | 2008-02-04 |
| Date of Event | 2008-01-29 |
| Date Added to Maude | 2008-02-15 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROCHE/HITACHI TINA-QUANT ALBUMIN ASSAY ON MODULAR P |
| Generic Name | URINE MICROALBUMIN ASSAY |
| Product Code | DCF |
| Date Received | 2008-02-04 |
| Model Number | TINA-QUANT |
| Catalog Number | 03576108 190 |
| Lot Number | 691-765-01 ALBUMIN |
| Device Expiration Date | 2009-05-31 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 966594 |
| Manufacturer | ROCHE DIAGNOSTICS CORP |
| Manufacturer Address | 9115 HAGUE RD PO BOX 50457 INDIANAPOLIS IN 462500457 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-04 |