BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    911 HITACHI

    MDR report key: 1221550 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08196
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING ERRONEOUS RESULTS FOR AST AND ALT FOR APPROXIMATELY FIVE DAYS. APPROXIMATELY 10 PT SAMPLES WERE AFFECTED. FOUR EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL ALT RESULT 8 U/L, REPEAT 4 U/L. SAMPLE 2 INITIAL AST RESULT <4 U/L, REPEAT 16 U/L; INITIAL ALT RESULT 5 UL, REPEAT 10 U/L. SAMPLE 3 INITIAL AST RESULT 5 U/L, REPEAT 18 U/L. SAMPLE 4 INITIAL ALT RESULT <4 U/L, REPEAT 9 U/L NO ERRONEOUS RESULTS WERE REPORTED. USER REPLACED THE ABSORBANCE PHOTOMETER LAMP WHICH RESOLVED THE ISSUE. NO FURTHER PROBLEMS HAVE OCCURRED SINCE THE LAMP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 911 HITACHI CLINICAL CHEMISTRY ANALYZER- JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK