BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1812935 · Received August 24, 2010

    Report

    Report Number
    1823260-2010-05026
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 24, 2010
    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 USER RECEIVED QUESTIONABLE RESULTS FOR HBA1C ON THE INTEGRA 400 PLUS ANALYZER. TWO PATIENT SAMPLES WERE INVOLVED IN THE EVENT. ONE PATIENT SAMPLE GAVE DISCREPANT RESULTS. THE INITIAL HBA1C RESULT GAVE 9.2 %. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON (B)(6) 2010 GIVING 7.9%. ON (B)(6) 2010, THE USER REPEATED THE SAMPLE GIVING A RESULT OF 7.1%. A CORRECTED REPORT WAS ISSUED WITH A HBA1C RESULT OF 7.1%. NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THIS DISCREPANCY. THE HBA1C REAGENT LOT NUMBER WAS 62769101. ALTHOUGH THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE AND COULD NOT REPRODUCE THE ISSUE, HE FOUND THE WASH SYRINGE WAS DAMAGED. HE REPLACE THE ENTIRE PIPETTING MODULE AND RAN PERFORMANCE TESTS WHICH PASSED SUCCESSFULLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1