MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-01-19 for COBAS 6000 C501 MODULE 05036453001 manufactured by Roche Diagnostics.
[8967891]
A specific root cause was not determined. The customer was educated regarding proper product handling.
Patient Sequence No: 1, Text Type: N, H10
[21638387]
The customer had on-going c-reactive protein gen. 3 (crp) calibration issues and received questionable results for an unknown number of patient samples. She provided crp results for three patient samples, results for one patient were discrepant. Both initial and repeat testing were performed on the same cobas 6000 c501 analyzer. The initial result was 102. 72 mg/l. The sample was repeated on (b)(6) 2010 and recovered 23. 11 mg/l. The initial result was reported outside the laboratory, no adverse events have been alleged regarding the discrepancies. The crp reagent lot number was 63067501. The customer believed a possible cause of the issue may have been improper calibrator handling (including not using the correct calibrator or inadequate calibrator volume). Another possible cause was a software issue which would account for the missing k factor. Improper data management could lead to a software issue. According to the customer, crp calibration and quality control were not performed prior to testing the patient samples.
Patient Sequence No: 1, Text Type: D, B5
[21855840]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-00282 |
| MDR Report Key | 1964070 |
| Report Source | 05,06 |
| Date Received | 2011-01-19 |
| Date of Report | 2011-01-26 |
| Date of Event | 2010-12-25 |
| Date Mfgr Received | 2010-12-27 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | NQD |
| Date Received | 2011-01-19 |
| 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 | 2011-01-19 |