BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03950

    MDR report key: 4996676 · Received August 12, 2015

    Report

    Report Number
    1823260-2015-03950
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    June 3, 2015
    Report Date
    September 2, 2015
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE FIRST ANALYZER PERFORMANCE CHECK (APC) WAS NOT ACCEPTABLE. THE FIELD SERVICE ENGINEER CHECKED THE TUBE & SAMPLE ALIGNMENT AND MADE ADJUSTMENTS. AFTER PERFORMING THIS SERVICE ACTION, THE 2ND APC TEST WAS ACCEPTABLE. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE IS NOT LIKELY. A POSSIBLE ROOT CAUSE MAY BE RELATED TO A SAMPLE PIPETTING ERROR CAUSED BY NOT USING RACK ADAPTERS IN COMBINATION WITH WET INNER TUBE WALLS. AN UNKNOWN INSTRUMENT ISSUE COULD ALSO HAVE CONTRIBUTED TO THE EVENT SINCE THE APC TEST PASSED ONLY AFTER SERVICE ACTIONS WERE PERFORMED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TROPONIN T HS (HIGH SENSITIVE) TROPONIN T HS. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TROPONIN T HS RESULT WAS 6.58 PG/ML. THE REPEAT RESULT WAS 45.04 PG/ML. THE RESULT OF 45.04 PG/ML RESULT WAS CONSIDERED TO BE CORRECT AND WAS REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENT OCCURRED. THE TROPONIN T HS REAGENT LOT NUMBER WAS 181799. THE EXPIRATION DATE WAS NOT PROVIDED. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE. IT WAS NOTED THAT THE CUSTOMER USES 13 MM PRIMARY TUBES WITHOUT RACK ADAPTERS.

    Patients

    Seq Age Sex Outcome Treatment
    1