BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1237598 · Received November 10, 2008

    Report

    Report Number
    1823260-2008-08297
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 21, 2008
    Report Date
    November 10, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    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 RECEIVED DISCREPANT ALT RESULTS FOR 2 PATIENT SAMPLES. SAMPLE 1 INITIALLY RECOVERED 5 U/L AND REPEATED AT 11 U/L AND 4 U/L. SAMPLE 2 INITIALLY RECOVERED 12 U/L AND REPEATED AT 19 U/L AND 10 U/L. USER DID NOT REPORT THE ERRONEOUS SAMPLE VALUES. TROUBLESHOOTING DETERMINED THAT A REAGENT MAY HAVE BEEN PREPARED INCORRECTLY. THE USER RESOLVED THE ISSUE BY CORRECTLY PREPARING FRESH REAGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL D MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK