BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C111

    MDR report key: 3200049 · Received July 1, 2013

    Report

    Report Number
    1823260-2013-03965
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 7, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K071211
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED QUESTIONABLE RESULTS FOR EIGHT PATIENT SAMPLES WHEN TESTED FOR GAMMA-GLUTAMYLTRANSFERASE VER.2 (GGT). TESTING ON THE EIGHT SAMPLES TOOK PLACE FROM (B)(6) 2012 THROUGH (B)(6) 2013. OF THESE EIGHT SAMPLES, ONE SAMPLE HAD AN ERRONEOUS RESULT THAT WAS REPORTED OUTSIDE THE LABORATORY. THE INITIAL GGT WAS 173 U/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE TEST WAS REPEATED ON (B)(6) 2013 WITH A RESULT OF 17 U/L. THE SAMPLE WAS SENT TO A PRIVATE HOSPITAL, WHICH OBTAINED A RESULT OF 20 U/L. THE REPEAT TEST WAS CONSIDERED TO BE CORRECT. THE PATIENT WAS NOT HARMED BY ANY ACTION TAKEN. THE GGT REAGENT LOT NUMBER WAS 676057; THE CUSTOMER WAS ASKED FOR THE EXPIRATION DATE BUT DID NOT PROVIDE IT. DUE TO LACK OF RELEVANT DATA PROVIDED BY THE CUSTOMER, A ROOT CAUSE COULD NOT BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298098 COBAS C111 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 059 YR