BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 2327546 · Received November 8, 2011

    Report

    Report Number
    1823260-2011-06034
    Event Type
    Malfunction
    Date Received
    November 8, 2011
    Date of Event
    October 19, 2011
    Report Date
    April 9, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. CALIBRATION AND QUALITY CONTROL WERE WITHIN SPECIFICATION, AND THE INFORMATION PROVIDED DOES NOT INDICATE AN ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE RESULT FOR TROPONIN T STAT (TNT) ON THEIR COBAS 6000 CORE 3 UNIT. THE PATIENT'S TNT RESULT FROM CORE 3 WAS 0.022 NG/ML USING REAGENT LOT NUMBER 16435401 WITH EXPIRATION DATE OF 08/31/2012. THE PATIENT'S TNT RESULT FROM CORE 1 WAS 0.029 NG/ML USING REAGENT LOT NUMBER 162343. THE PATIENT'S TNT RESULT FROM CORE 2 WAS 0.029 NG/ML USING REAGENT LOT NUMBER WAS 164354. THE CUSTOMER CONSIDERS THE RESULT FROM CORE 1 TO BE CORRECT. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE CUSTOMER DECLINED A SERVICE VISIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1