BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2016-02004

    MDR report key: 6187345 · Received December 19, 2016

    Report

    Report Number
    1823260-2016-02004
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    December 7, 2016
    Report Date
    January 24, 2017
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF THE CALIBRATION AND QUALITY CONTROL DATA PROVIDED, THE RESULTS ARE WITHIN THE EXPECTED RANGES AND DO NOT SUGGEST AN INSTRUMENT PROBLEM.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION STATED THAT WORN PINCH TUBING ALLOWS LIQUID TO LEAK AFFECTING THE ACCURACY OF PIPETTING VOLUMES AND THE ABILITY TO PROPERLY CLEAN THE MEASURING CELL. IT COULD NOT BE DETERMINED WHY THE SIPPER PROBE WAS OUT OF ALIGNMENT. CARELESSNESS BY THE OPERATOR COULD CAUSE THIS TO OCCUR SINCE THE SIPPER PROBE IS SENSITIVE AND ABLE TO BE ACCESSED INSIDE THE INSTRUMENT.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ELECSYS TROPONIN T STAT ASSAY (TROPONIN T STAT) RESULTS THAT WERE INITIALLY NEGATIVE, BUT WHEN THE SAMPLE WAS REPEATED, THE RESULTS WERE POSITIVE. THE CUSTOMER STATED THIS HAPPENED 3 TIMES BETWEEN (B)(6) 2016. THE CUSTOMER INDICATED THAT ALL NEGATIVE RESULTS ARE AUTOMATICALLY VERIFIED PRIOR TO REPORTING OUTSIDE OF THE LABORATORY AND THAT CURRENTLY ALL TROPONIN T STAT RESULTS ARE BEING PERFORMED IN DUPLICATE TO MAKE SURE THE RESULTS ARE CORRECT. THE CUSTOMER PROVIDED DATA FOR 2 PATIENT SAMPLES WHERE THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. ONE PATIENT SAMPLE WAS ERRONEOUS WHEN TESTED FOR TROPONIN T STAT AND ONE PATIENT SAMPLE WAS ERRONEOUS WHEN TESTED FOR ELECSYS HCG + BETA TEST SYSTEM (HCG + B). PATIENT 1 INITIAL TROPONIN T STAT RESULT WAS 0.01 NG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 0.37 NG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. PATIENT 2 INITIAL HCG + B RESULT WAS <0.06 MIU/ML. THE REPEAT RESULT WAS 249.3 MIU/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THERE WERE NO ADVERSE EVENTS. THE TROPONIN T STAT LOT NUMBER WAS 153496. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE LOT NUMBER AND REAGENT LOT FOR HCG +B WERE REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND FOUND THE SIPPER PINCH TUBING WAS WORN AND STICKING CLOSED. THE SIPPER PROBE WAS ALSO OUT OF ALIGNMENT AT THE ASPIRATION STATION. THE PINCH TUBING WAS REPLACED AND THE SIPPER PROBE WAS REALIGNED. SAMPLE/REAGENT PROBE TUBING WAS ALSO REPLACED. THE WATER SYSTEM FILTERS WERE CHECKED AND VERIFIED. INSTRUMENT TESTS WERE PERFORMED AND ALL PARAMETERS PASSED. THE CUSTOMER RERAN QUALITY CONTROLS WHICH WERE ACCEPTABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1