BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE OMNI 8

    MDR report key: 1051421 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04201
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K050423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PT SAMPLES WITH DISCREPANT GLUCOSE RESULTS WHEN COMPARED TO REPEAT TESTING ON ANOTHER ANALYZER. PT 1, INITIAL RESULT GAVE 141 MG/DL, REPEAT GAVE 188 MG/DL. PT 2, INITIAL RESULT GAVE 131 MG/DL; REPEAT GAVE 176 MG/DL. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE DUE TO A DEFECTIVE SD CARTRIDGE AND MSS COMPLETE, AND REPLACED SD CARTRIDGE AND MSS COMPLETE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE OMNI 8 BLOOD GAS ANALYZER - CHL CHL ROCHE DIAGNOSTICS OMNI 8

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK