MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-10-11 for REFLOTRON POTASSIUM 11208764202 manufactured by Roche Diagnostics Corp..
[1365608]
User experienced 3 patient samples with discrepant potassium results between 2 different methods as follows: sample 1, initial result 4. 69 mmol/l, repeat using different method 5. 4 mmol/l. Sample 2, initial result 3. 33 mmol/l, repeat using different method 4. 5 mmol/l. Sample 3, initial result 3. 93 mmol/l, repeat using different method 4. 6 mmol/l. If additional information is received, appropriate notification will be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2007-08878 |
| MDR Report Key | 1766180 |
| Report Source | 05,06 |
| Date Received | 2007-10-11 |
| Date of Report | 2007-10-11 |
| Date of Event | 2007-09-17 |
| Date Facility Aware | 2007-09-17 |
| Report Date | 2007-09-17 |
| Date Mfgr Received | 2007-09-17 |
| Date Added to Maude | 2010-08-31 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | SALLY BOWDEN |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214668 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFER STRASSE 116 |
| Manufacturer City | MANNHEIM 68305 |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFLOTRON POTASSIUM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER - CEJ |
| Product Code | CEJ |
| Date Received | 2007-10-11 |
| Catalog Number | 11208764202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS CORP. |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-11 |