MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-08 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[3039290]
The customer alleged they received questionable mb isoenzyme of creatine kinase (ck-mb) results on their e601 analyzer. The customer stated they had two patients with discrepant results that were reported outside the laboratory. The customer noticed the discrepancy while performing a patient comparison to switch to the ck-mb stat reagent. The repeat testing was performed on (b)(6) 2012 on the original c601 analyzer and a cobas 8000 e602 analyzer, serial number not provided. The first patient's initial ck-mb result was 1. 54 ng/ml. The repeat ck- mb result from the e601 analyzer was 7. 55 ng/ml. The repeat ck-mb result from the e602 analyzer was 7. 60 ng/ml. The second patient's initial ck-mb result was 0. 979 ng/ml. The repeat ck-mb result from the e601 analyzer was 27. 86 ng/ml. The repeat ck-mb result from the e602 analyzer was 29. 07 ng/ml. The repeat results from the e602 analyzer were considered correct and they were issued as corrected reports. No action was taken by the physician due to the discrepant results. There were no adverse events. The ck-mb reagent lot number was 16604501 and the expiration date was 10/31/2012. The field service representative thought there might have been a problem with the measuring cell. As the measuring cells were nearing the end of their life span, he replaced both measuring cells on the analyzer. He performed the preparation steps for the new cells, deleted previous calibrations, and calibrated a new blank cell factor. He ran performance testing with passing results. All assays on board were recalibrated and had quality control performed with passing results.
Patient Sequence No: 1, Text Type: D, B5
[10188777]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2012-05012 |
| MDR Report Key | 2775909 |
| Report Source | 05,06 |
| Date Received | 2012-10-08 |
| Date of Report | 2012-10-08 |
| Date of Event | 2012-09-24 |
| Date Mfgr Received | 2012-09-26 |
| Date Added to Maude | 2012-10-08 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| 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 | JLB |
| Date Received | 2012-10-08 |
| Model Number | NA |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-10-08 |