BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C502 MODULE

    MDR report key: 4170042 · Received October 14, 2014

    Report

    Report Number
    1823260-2014-07858
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 4, 2014
    Report Date
    January 5, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 (ALB), TOTAL PROTEIN URINE/CSF GEN.3 (UPRO), AND CREATININE FOR ONE PATIENT. THE CUSTOMER PROVIDED DATA FOR DISCREPANT ALB AND UPRO RESULTS ON THEIR C502 ANALYZER. THE PATIENT'S RESULTS WERE FROM A URINE SAMPLE. THE UNITS OF MEASURE WERE REQUESTED BUT NOT PROVIDED. THE PATIENT'S INITIAL ALB RESULT WAS 2.5 AND UPRO RESULT WAS 0.61. THE RESULTS WERE AUTO-ACCEPTED AND REPORTED TO THE CUSTOMER'S LABORATORY INFORMATION SYSTEM. THE PATIENT'S SAMPLE WAS THEN TESTED ON ANOTHER C502 ANALYZER. THE PATIENT'S ALB RESULT WAS 654.7 ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED WITH DECREASED VOLUME AND THE RESULT WAS 930. THE PATIENT'S UPRO RESULT WAS 1.84. THE SAMPLE WAS REPEATED AGAIN ON THE OTHER C502 ANALYZER. THE PATIENT'S ALB RESULT WAS 687.9 ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED WITH DECREASED VOLUME AND THE RESULT WAS 908.6. THE PATIENT'S UPRO RESULT WAS 1.85. THERE WERE NO ADVERSE EVENTS. THE ALB REAGENT LOT NUMBER WAS 699769 AND THE UPRO REAGENT LOT NUMBER WAS 697110. THE EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651945 COBAS 8000 C502 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1