BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 700

    MDR report key: 1780200 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08249
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    September 4, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATES THAT THEY GOT LOW PATIENT RESULTS AND GAVE AN EXAMPLE OF A PATIENT SAMPLE THAT INITIALLY GAVE A RESULT OF 3 MG/DL FOR GLUCOSE AND REPEATED AS 92 MG/DL ON ANOTHER ANALYZER. THE INCORRECT RESULTS WERE NOT REPORTED. IT WAS DETERMINED THE ST1 PROBE WAS CLOGGED AND THE ACCOUNT REPAIRED THE INSTRUMENT BY REPLACING THE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 700 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA