BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 1010

    MDR report key: 1063643 · Received June 19, 2008

    Report

    Report Number
    1823260-2008-04850
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    October 17, 2007
    Report Date
    June 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTS FAILING OUT LOW ON TWO EXTERNAL PROFICIENCY SURVEY SAMPLES FOR CKMB. SURVEY SAMPLE 1: REPORTED RESULT 35.9 NG/ML. ACCEPTABLE SURVEY RANGE 49.4 TO 66.7 NG/ML. SURVEY SAMPLE REPEATED TWICE; IN LATE 2007 GAVE 27.21 NG/ML, AND IN EARLY 2007 GAVE 33.75 NG/ML. A NEW SURVEY SAMPLE WAS OBTAINED AND ON TWELVE DAYS AFTER THE ORIGINAL DATE RESULTED AT 30.65 NG/ML; REPEATED AN ADDITIONAL THREE TIMES; INITIALLY ON 01/17/08 GAVE 39.95 NG/ML, IN 2008 USING DIFFERENT ANALYZER GAVE 56.22 NG/ML AND ON SIX DAYS LATER, USING INITIAL ANALYZER GAVE 58.30 NG/ML. SURVEY SAMPLE 2: REPORTED SURVEY RESULT 49.39 NG/ML. ACCEPTABLE SURVEY RANGE 62.1 TO 85.2 NG/ML. SURVEY SAMPLE REPEATED TWICE, ON ORIGINAL DATE GAVE 27.60 NG/ML, AND IN EARLY 2008 GAVE 48.38 NG/ML. A NEW SURVEY SAMPLE WAS OBTAINED AND IN LATE 2007 GAVE 38.89 NG/ML; REPEATED AN ADDITIONAL THREE TIMES, INITIALLY IN 2008 GIVING 48.10 NG/ML, ON FOUR AND A HALF MONTHS LATER, USING DIFFERENT ANALYZER GAVE 74.50 NG/ML AND ON THE SAME DAY, USING INITIAL ANALYZER GAVE 69.30 NG/ML. NO PATIENT SAMPLES WERE REPORTED TO HAVE BEEN INVOLVED. THE FIELD SVC REP DETERMINED THE CAUSE TO BE DUE TO A FAULTY MEASURING CELL AND REPLACED THE MEASURING CELL. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 1010 IMMUNOCHEMISTRY ANALYZER - JJE MMI ROCHE DIAGNOSTICS 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK