BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1052450 · Received May 22, 2008

    Report

    Report Number
    1823260-2008-04268
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 5, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTS FAILING THREE EXTERNAL PROFICIENCY SURVEY SAMPLES FOR DIGOXIN, AND WHEN REPEATED GAVE DISCREPANT RESULTS. SURVEY SAMPLES WERE REPEATED THREE TIMES, SAME DAY AS INITIAL RESULT, IN 2008 AND ABOUT 11 DAYS LATER. SURVEY #1: INITIAL RESULT REPORTED GAVE 2.3 NG/ML; REPEATS GAVE 2.1, 3.2 AND 3.0 NG/ML. ACCEPTABLE SURVEY RANGE 2.6 TO 4.0 NG/ML. SURVEY #2: INITIAL RESULT REPORTED GAVE 1.6 NG/ML; REPEATS GAVE 2.0 TWICE AND 2.4 NG/ML. ACCEPTABLE SURVEY RANGE 1.9 TO 3.0 NG/ML. SURVEY #3: INITIAL RESULT REPORTED GAVE 1.3 NG/ML; REPEATS GAVE 1.7, 1.6 AND 1.9 NG/ML. ACCEPTABLE SURVEY RANGE 1.5 TO 2.3 NG/ML. NO PATIENT SAMPLES WERE INVOLVED. ALTHOUGH THE EXACT ROOT CAUSE WAS NOT DETERMINED, THE FIELD SERVICE REP REPLACED THE MEASURING CELL, CLEANED S/R PROBE AND VERIFIED ALIGNMENT OF TUBING FROM MEASURING CELL TO SIPPER NOZZLE AND MIXING SPEED. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 DISK IMMUNOCHEMISTRY ANALYZER- JJE JJE ROCHE DIAGNOSTICS 2010 DISK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK