BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 1973066 · Received January 28, 2011

    Report

    Report Number
    1823260-2011-00508
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 15, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. CALIBRATION AND QUALITY CONTROLS CONNECTED TO THE EVENT WERE WITHIN SPECIFICATION. ASSAY PERFORMANCE CHECKS PERFORMED BY THE FIELD SERVICE REPRESENTATIVE WERE WITHIN SPECIFICATION. NO ISSUE WAS FOUND. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER EXPERIENCED AN ONGOING ISSUE WITH QUESTIONABLE TROPONIN T RESULTS AND PROVIDED DATA FOR ONE PATIENT SAMPLE. THE RESULT WITH THE TROPONIN T REAGENT WAS 0.265 NG/ML WITH A DATA FLAG AND THE RESULT WITH THE TROPONIN T STAT GENERATION 4 REAGENT WAS <0.010 NG/ML WITH A DATA FLAG. THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING AND THE RESULT WAS <0.010 NG/ML. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS WERE ALLEGED. THE TROPONIN T REAGENT LOT NUMBER WAS 15930001 AND THE TROPONIN T STAT GENERATION 4 REAGENT LOT NUMBER WAS 15989401. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE AND COULD NOT DUPLICATE THE ISSUE. HE CHECKED THE INSTRUMENT AND RAN PERFORMANCE TESTING TO VERIFY THE ANALYZER OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1