BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 2022203 · Received March 17, 2011

    Report

    Report Number
    1823260-2011-01453
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KTO
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE IMMUNOGLOBULIN IGG GENERATION 2 (IGG) RESULTS FOR ONE PATIENT. THE INITIAL RESULT WAS 861 MG/DL. THE REPEAT RESULTS ON (B)(6) 2011 WERE 279 MG/DL USING AN ALIQUOT TESTED ON THE COBAS C501 ANALYZER, 759 MG/DL ON THE COBAS INTEGRA 800 ANALYZER AND 710 MG/DL ON THE COBAS C501 ANALYZER. IT WAS UNKNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE REPORTED. THE IGG REAGENT LOT NUMBER WAS 633089. THE INVESTIGATION WAS NOT ABLE TO DETERMINE A SPECIFIC ROOT CAUSE DUE TO INSUFFICIENT DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 CORE CLINICAL CHEMISTRY ANALYZER KTO ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1