BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1901913 · Received November 18, 2010

    Report

    Report Number
    1823260-2010-06797
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR GLUCOSE HK GENERATION 3 (GLUC3), PHOSPHATE (INORGANIC) VERSION 2 (PHOS2), AND ALKALINE PHOSPHATASE IFCC GENERATION 2 (ALP2) ON THE INTEGRA 800 ANALYZER. THE EVENT INVOLVED ONE PATIENT SAMPLE WHICH GAVE DISCREPANT RESULTS. THE PATIENT SAMPLE WAS REPEATED ON (B)(6) 2010 ON A COBAS 6000 C501 ANALYZER. THE INITIAL RESULT FOR GLUC3 WAS 429 MG/DL; THE REPEAT RESULT WAS 72 MG/DL. THE INITIAL RESULT FOR PHOS2 WAS 8.8 MG/DL; THE REPEAT RESULT WAS 3.6 MG/DL. THE INITIAL RESULT FOR (ALP2) WAS 214 U/L; THE REPEAT RESULT WAS 73 U/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT AFFECTED BY THE EVENT. THE REAGENT LOT FOR GLUC3 WAS 61943801. THE REAGENT LOT FOR PHOS2 WAS 62797901. THE REAGENT LOT FOR ALP2 WAS 63013201. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS FLUIDICS FAILURE AND MISADJUSTED TUBE DEFINITIONS AND SAMPLE SPLASHGUARD HOLDER. HE REPLACED MULTIPLE COMPONENTS AND PERFORMED ADJUSTMENTS. PERFORMANCE TESTS WERE RUN WHICH WERE ACCEPTABLE.

    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
    1 075 YR