MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-09-18 for REFLOTRON POTASSIUM 1208764 manufactured by Roche Diagnostics.
[677192]
The reporter called and alleged discrepant results on the device when compared to a lab. The results reported were: see scanned table. Controls were out of range and the reporter said controls were rerun with newly reconstituted controls which were in range. The device was replaced and requested to be returned for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2006-05163 |
| MDR Report Key | 884466 |
| Report Source | 06 |
| Date Received | 2006-09-18 |
| Date of Report | 2006-08-29 |
| Date of Event | 2006-08-21 |
| Date Mfgr Received | 2006-08-29 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2007-07-25 |
| 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 | 0 |
| 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 | SANDHOFERSTRASSE 116 |
| Manufacturer City | MANNHEIM 68298 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68298 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLOTRON POTASSIUM |
| Generic Name | CLINICAL CHEMISTRY REAGENT TEST STRIP |
| Product Code | CEJ |
| Date Received | 2006-09-18 |
| Model Number | NA |
| Catalog Number | 1208764 |
| Lot Number | 23698231 |
| ID Number | NA |
| Device Expiration Date | 2007-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 862859 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | * INDIANAPOLIS IN * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-18 |