BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 2002715 · Received February 28, 2011

    Report

    Report Number
    1823260-2011-01060
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 21, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. THE ISSUE WAS RESOLVED BY THE IMPLEMENTATION OF AN EXTRA WASH CYCLE AFTER THE CHOLESTEROL ASSAY BEFORE AND BEFORE THE CREATININE ASSAY. IN ADDITION, THE TEST ORDER WAS CHANGED ON THE ANALYZER. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE CREATININE PLUS GENERATION 2 (CREATININE) RESULTS AND PROVIDED DATA FOR THREE PATIENT SAMPLES. ALL RESULTS ARE IN MG/DL. PATIENT SAMPLE 1 INITIAL RESULT WAS 19.7 AND THE REPEAT RESULTS WERE 8.1 AND 7.9. PATIENT SAMPLE 2 WAS FROM A FEMALE PATIENT BORN ON (B)(6). THE INITIAL RESULT WAS 16.1 AND THE REPEAT RESULTS WERE 7.7 AND 7.8. ON (B)(6) 2011, PATIENT SAMPLE 3 FROM A FEMALE PATIENT BORN ON (B)(6) WAS TESTED. THE INITIAL RESULT WAS 14.8 AND THE REPEAT RESULTS WERE 8.1 AND 8.1. A PRECISION TEST OF 20 SAMPLINGS WAS PERFORMED USING THIS PATIENT SAMPLE AND THE RESULTS WERE BETWEEN 7.7 AND 8.5. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE EVENT. THE CREATININE REAGENT LOT NUMBERS WERE 6348501 AND 637419.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 043 YR