MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-09-23 for COBAS 6000 C501MODULE 04745914001 manufactured by Roche Diagnostics.
[1173529]
Customer states they assayed a pt sample for calcium and recovered result of 0. 3 mg per dl. This result was accompanied by a data flag notifying the user the result is outside the technical limit of the assay. The analyzer auto reran the sample and recovered 0. 4 mg per dl. The technician reported the 0. 4 mg per dl result. On (b)(6) 2009, the physician questioned the result and the sample was pulled and rerun. At that time, the result recovered was 9. 9 mg per dl. Customer states the pt was redrawn and the second sample result was 9. 6 mg per dl. No other assays were affected. The pt was not treated based on this erroneous result. The field service representative did not find a cause. He performed a precision on calcium and several other tests to verify analyzer operation. Precision results were good on all tests and the field service representative observed proper analyzer mechanical operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2009-06291 |
| MDR Report Key | 1504870 |
| Report Source | 05,06 |
| Date Received | 2009-09-23 |
| Date of Report | 2009-09-23 |
| Date of Event | 2009-09-03 |
| Date Facility Aware | 2009-09-09 |
| Report Date | 2009-09-09 |
| Date Mfgr Received | 2009-09-09 |
| Date Added to Maude | 2009-12-22 |
| 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 C501MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER - CEM |
| Product Code | JFP |
| Date Received | 2009-09-23 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| 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 | 2009-09-23 |