BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HITACHI 917 DISK

    MDR report key: 1761061 · Received July 19, 2007

    Report

    Report Number
    1823260-2007-06279
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    June 27, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATED THEY HAD SEVERAL DISCREPANT CO2 RESULTS AS FOLLOWS (INITIAL RESULT/REPEAT(S) MMOL/L): #1- 8/16,19; #2- 17/26; #3 6/9,25; #4- 14/12,25; #5- 12/12/33; #6- <1.5/10; #7- <1.5/7,26. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP FOUND THE SAMPLE PROBE WAS MISALIGNED AND REPAIRED THE INSTRUMENT BY REALIGNING THE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HITACHI 917 DISK CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA