MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-05-10 for REFLOTRON PLUS V 03012573001 manufactured by Roche Diagnostics.
[20932141]
Comparison of uric acid test results did not match. Initial sample result of 2. 74 mg/dl. The same sample was tested using a different methodology and recovered 8. 9 mg/dl. If additional info is received, appropriated notification will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2007-03994 |
| MDR Report Key | 965851 |
| Report Source | 05,06 |
| Date Received | 2007-05-10 |
| Date of Report | 2007-05-10 |
| Date of Event | 2007-04-09 |
| Date Facility Aware | 2007-04-13 |
| Report Date | 2007-04-13 |
| Date Mfgr Received | 2007-04-13 |
| Date Added to Maude | 2007-12-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | FERN DELACROIX |
| Manufacturer Street | 9115 HAGUE RD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217494 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFER STRASSE 116 |
| Manufacturer City | MANNHEIM D68305 08 68305 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 08 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLOTRON PLUS V |
| Generic Name | REFLOTRON URIC ACID, COLORIMETRIC - KNK |
| Product Code | KNK |
| Date Received | 2007-05-10 |
| Model Number | PLUS V |
| Catalog Number | 03012573001 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 935503 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | * INDIANAPOLIS IN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-10 |