MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-12-16 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[15701180]
The user stated they had a lithium result of 1. 5 mmol per l that was reported to the physician. The physician questioned the result because the pt was not on lithium and had the pt redrawn. The result from the redraw specimen was 0 mmol per l. The user reran the original serum specimen and recovered a result of 0 mmol per l. The pt was not adversely affected. The field service representative was unable to find a cause. He inspected the c501 for proper rinse mechanism aspiration, dispense of the reaction cells, wash station proper rinse volume and all probes for proper alignments. He verified the analyzer performance with mechanism checks and had the user perform calibration and qc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2009-08511 |
| MDR Report Key | 1564505 |
| Report Source | 05,06 |
| Date Received | 2009-12-16 |
| Date of Report | 2009-12-16 |
| Date of Event | 2009-11-30 |
| Date Facility Aware | 2009-12-03 |
| Report Date | 2009-12-03 |
| Date Mfgr Received | 2009-12-03 |
| Date Added to Maude | 2010-04-23 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | HITACHI HIGH TECH. CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER - CEM |
| Product Code | NDW |
| Date Received | 2009-12-16 |
| Model Number | C501 |
| Catalog Number | 05036453001 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-16 |