BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1371948 · Received February 13, 2009

    Report

    Report Number
    1823260-2009-01190
    Event Type
    Malfunction
    Date Received
    February 13, 2009
    Date of Event
    January 23, 2009
    Report Date
    February 13, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RAN A PT SAMPLE WHICH GENERATED A HIGH BILIRUBIN RESULT AND NO PROZONE ERROR. THE PT HAD A HIGH IGC RESULT AND THE CUSTOMER WAS EXPECTING A PROZONE ERROR TO ACCOMPANY THE RESULT. SAME SAMPLE WAS RUN ON ANOTHER ANALYZER AND A PROZONE ERROR DID OCCUR. INITIAL TOTAL BILIRUBIN RESULT 24.8 MG PER DL, REPEATED ONE TIME, IN EARLY 2009, ON THIS ANALYZER GAVE 26.5 MG PER DL (WITH NO PROZONE ERRORS). SAME SAMPLE REPEATED ON ANOTHER ANALYZER, IN EARLY 2008, GAVE 27.3 AND 11.5 MG PER DL (WITH PROZONE ERRORS ON BOTH RESULTS). ERRONEOUS RESULTS WERE REPORTED, IT IS UNK IT THE PT WAS ADVERSELY AFFECTED. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS MODULAR CORE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK