MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-11-09 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[1392002]
The user stated they had one sample in a 7 ml gold top serum tube which generated a theophylline result of 0 ug per ml with a data flag and the result was reported as less than 0. 8 ug per ml. The tech reran the sample and received a result of 20. 5 ug per ml. They created corrective report and the patient was not adversely affected. The field service rep could not duplicate the issue. He also checked the probe alignments. To verify the analyzer operation, he performed qc and ran a precision and a check test with proper results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2009-07678 |
| MDR Report Key | 1549252 |
| Report Source | 05,06 |
| Date Received | 2009-11-09 |
| Date of Report | 2009-11-09 |
| Date of Event | 2009-10-14 |
| Date Facility Aware | 2009-10-16 |
| Report Date | 2009-10-16 |
| Date Mfgr Received | 2009-10-16 |
| Date Added to Maude | 2010-05-17 |
| 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 | 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 | KLS |
| Date Received | 2009-11-09 |
| Model Number | C501 |
| Catalog Number | 05036453001 |
| 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 |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-09 |