BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C (701) MODULE

    MDR report key: 7494276 · Received May 8, 2018

    Report

    Report Number
    1823260-2018-01414
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 18, 2018
    Report Date
    May 8, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR 4 PATIENT SAMPLES ON THE COBAS 8000 C (701) MODULE. FOR PATIENT 1 THE CA2 RESULT WAS 0.90 MMOL/L AND THE RESULT ON A BECKMAN COULTER WAS 2.32 MMOL/L. FOR PATIENT 2 THE CA2 RESULT WAS 0.81 MMOL/L AND THE RESULT ON A BECKMAN COULTER WAS 2.45 MMOL/L. FOR PATIENT 3 THE CA2 RESULT WAS 1.18 MMOL/L AND THE RESULT ON A BECKMAN COULTER WAS 2.1 MMOL/L. FOR PATIENT 4 THE CA2 RESULT WAS 1.06 MMOL/L AND THE RESULT ON A BECKMAN COULTER WAS 2.19 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER RANDOMLY COULD NOT CALIBRATE AND RECEIVED CALIBRATION ALARMS. THE CA2 REAGENT LOT NUMBER WAS 221425 WITH AN EXPIRATION DATE OF 31-MAY-2018. THE FIELD SERVICE ENGINEER (FSE) CHECKED THE REAGENT PROBES, SAMPLE PROBE, AND RINSE NOZZLE. THE FSE FOUND THAT THE RINSE NOZZLE WAS NOT WORKING PROPERLY AND THAT MORE NAOH WAS BEING PUMPED INTO THE CUVETTES THAN NORMAL. A SAMPLE THAT PREVIOUSLY HAD A DISCREPANT CA2 RESULT WAS RUN 5 TIMES AND THE RESULTS MATCHED THE OTHER INSTRUMENT. THE INVESTIGATION DETERMINED THAT THE ISSUE FOUND BY THE FSE WAS THE ROOT CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338067 COBAS 8000 C (701) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1