MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-12-10 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[1675670]
The user received questionable low results intermittently for multiple assays on the cobas 6000 c501 analyzer. The event involved seven patient samples. Two patient samples gave discrepant results for cholesterol generation 2 (chol2) which occurred on (b)(6) 2010. Patient sample 1, the initial result was 9 mg/dl, the repeat result was 196 mg/dl. Patient sample 2, the initial result was 9 mg/dl; the repeat result was 238 mg/dl. To the customers' knowledge, no erroneous results were reported outside the laboratory and did not expect that any patients were affected by the event. The reagent lot number for chol2 was 62476401. The field service representative determined the cause was a problem with the rinse unit operation. Multiple components were replaced and adjustments performed. Performance tests were run and within specification.
Patient Sequence No: 1, Text Type: D, B5
[8804486]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-07368 |
| MDR Report Key | 1920218 |
| Report Source | 05,06 |
| Date Received | 2010-12-10 |
| Date of Report | 2010-12-10 |
| Date of Event | 2010-11-29 |
| Date Mfgr Received | 2010-11-30 |
| Date Added to Maude | 2011-04-11 |
| 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 | NA ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| 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 NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 C501 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CHD |
| Date Received | 2010-12-10 |
| Model Number | NA |
| Catalog Number | 05036453001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-10 |