BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2775909 · Received October 8, 2012

    Report

    Report Number
    1823260-2012-05012
    Event Type
    Malfunction
    Date Received
    October 8, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLB
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JLB ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1