BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA 400+

    MDR report key: 843657 · Received October 12, 2006

    Report

    Report Number
    1823260-2006-05825
    Event Type
    Malfunction
    Date Received
    October 12, 2006
    Date of Event
    September 26, 2006
    Report Date
    September 26, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE PT SODIUM SAMPLES GAVE RESULTS OF 130/130/130 MMOL/L INITIALLY. WHEN REPEATED, THE RESULTS FOR THE THREE SAMPLES WERE 146/136/147 MMOL/L. THE INCORRECT RESULTS WERE NOT USED TO GUIDE THERAPY. THE FIELD SERVICE REP FOUND THE VALVE FOR PIPETTOR C WAS BAD AND REPAIRED THE INSTRUMENT BY REPLACING THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA 400+ CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 400+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR