BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1898679 · Received November 15, 2010

    Report

    Report Number
    1823260-2010-06730
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 21, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JMG
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS PROVIDED FOR INVESTIGATION. THE SAMPLE WAS TESTED USING A COBAS C501, USING FERRTIN REAGENT GENERATION 3 AND FERRITIN REAGENT GENERATION 4. THE SAMPLE WAS ALSO TESTED ON THE ELECSYS E411 ANALYZER, THE RESULTS FROM THE FERRITIN GENERATION 4 ASSAY WERE CONSISTENT TO THE FERRITIN RESULT ON THE ELECSYS E411. THE RESULT FROM THE GENERATION 4 ASSAY SHOULD BE RELIABLE. THE ROOT CAUSE FOR THE DIFFERENT RECOVERIES BETWEEN FERRITIN GENERATION 3 AND FERRITIN GENERATION 4 ASSAYS ON THE COBAS C501 INSTRUMENT MAY BE A SAMPLE SPECIFIC EFFECT, MOST LIKELY RELATED TO AN ENZYMATIC CLEAVAGE PROCESS, HOWEVER THIS COULD NOT BE CONFIRMED. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE WHILE PERFORMING A COMPARISON OF AT LEAST 12 SAMPLES USING DIFFERENT VERSIONS OF THE FERRITIN ASSAY. WITH THE FERRITIN GENERATION 3 REAGENT THE RESULT WAS 135 UG/L AND WITH THE FERRITIN GENERATION 4 REAGENT THE RESULT WAS 14.3 UG/L. THE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AS THE SAMPLES WERE TESTED FOR COMPARISON ONLY. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. THE PATIENT'S CURRENT CONDITION WAS "GOOD". THE FERRITIN GENERATION 3 REAGENT LOT NUMBER WAS 625157 AND THE FERRITIN GENERATION 4 REAGENT LOT NUMBER WAS 627701.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER JMG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR