MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-12-01 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[1811952]
The customer failed one external proficiency survey sample for the mb isoenzyme of creatinine kinase (ck-mb) and had been experiencing ck-mb quality control problems. The customer repeated the survey sample on the same cobas 6000 e601 module. The initial survey sample result generated by the customer was 54. 1 ng/ml. The survey sample mean was 64 ng/ml. The survey sample result when repeated was 62 ng/ml. The dates of initial and repeat testing were not provided by the customer. The ck-mb reagent lot number was not provided by the customer. The field service representative determined misadjusted high voltage on measuring cell #2 was the cause. He adjusted the voltage which resolved the issue. He performed calibrations and quality control which were acceptable.
Patient Sequence No: 1, Text Type: D, B5
[8807149]
The survey sample was repeated a second time and recovered 64. 7 ng/ml. The date of testing was not provided by the customer.
Patient Sequence No: 1, Text Type: N, H10
[8909237]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-07065 |
| MDR Report Key | 1911500 |
| Report Source | 05,06,07 |
| Date Received | 2010-12-01 |
| Date of Report | 2010-12-21 |
| Date of Event | 2010-11-11 |
| Date Mfgr Received | 2010-11-11 |
| Date Added to Maude | 2011-04-07 |
| 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 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JHS |
| Date Received | 2010-12-01 |
| Model Number | NA |
| Catalog Number | 04745922001 |
| 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 | 2010-12-01 |