BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1946296 · Received January 4, 2011

    Report

    Report Number
    1823260-2011-00004
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS. DATA FOR 6 PATIENT SAMPLES WAS PROVIDED, FOR WHICH THE ALBUMIN GEN. 2 (ALB) RESULT ON ONE SAMPLE WAS DISCREPANT. THE INITIAL ALB RESULT WAS 2.8 G/DL AND WAS REPORTED OUTSIDE THE LABORATORY. TESTING WAS REPEATED ON COBAS INTEGRA SERIAL NUMBER (B)(4) WITH AN ALB OF 3.8 G/DL. THE CUSTOMER DECIDED TO TAKE NO ACTION ON THIS DISCREPANCY AND STATED THE DIFFERENCE WAS NOT SIGNIFICANT ENOUGH TO CONTACT THE PHYSICIAN OR TO CORRECT THE RESULT. NO SERIOUS ADVERSE EVENTS WERE ALLEGED IN CONNECTION WITH THIS EVENT. THE ALB REAGENT LOT NUMBER WAS 63305101. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE EVENT WAS CAUSED BY A DEFECTIVE VALVE. HE REPLACED THE VALVE, PRIMED AND INITIALIZED THE SYSTEM, AND PERFORMED CHECKS. QUALITY CONTROLS WERE RUN AND WERE WITHIN ACCEPTABLE RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 048 YR