BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK

    MDR report key: 1191560 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07211
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 6, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT TROPININ T RESULTS FOR ONE PATIENT. INITIAL RESULT ON BASELINE SAMPLE GAVE 0.148 NG/ML, REPEAT IN 2008 GAVE <0.010 NG/ML. INITIAL RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. NO INFORMATION PROVIDED TO DETERMINE IF PATIENT WAS ADVERSELY AFFECTED. THE INVESTIGATION UNIT DID NOT VERIFY THE COMPLAINT AND COULD NOT DETERMINE THE EXACT REASON FOR THE FLLER. IT WAS NOTED THE APPROPRIATE CENTRIFUGATION PROCEDURES WERE NOT FOLLOWED. ADDITIONALLY, THE FIELD SERVICE REPRESENTATIVE ALIGNED THE TUBING, ADJUSTED THE HIGH VOLTAGE AND REPLACED THE MEASURING CELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK