BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03948

    MDR report key: 4996672 · Received August 12, 2015

    Report

    Report Number
    1823260-2015-03948
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 22, 2015
    Report Date
    August 10, 2015
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 STAT (HIGH SENSITIVE SHORT TURN AROUND TIME) TROPONIN T HS STAT. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER RAN A FRONT LOADED PRIMARY TUBE FROM ANOTHER LABORATORY AND THE INITIAL TROPONIN T HS STAT RESULT WAS 30.08 PG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN QUESTIONED THIS RESULT AS A RESULT LATER WAS <5 PG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 25.01 PG/ML. THE SAMPLE WAS RE-CENTRIFUGED AND AN ALIQUOT OF THE SAMPLE WAS REPEATED "SEVERAL" TIMES WITH RESULTS OF <3.00 PG/ML WITH DATA FLAGS. THE RESULTS OF <3.00 PG/ML WITH DATA FLAGS WERE CONSIDERED TO BE CORRECT. NO ADVERSE EVENT OCCURRED. THE TROPONIN T HS STAT REAGENT LOT NUMBER WAS 182603. THE EXPIRATION DATE WAS NOT PROVIDED. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE ERRONEOUS RESULTS WERE MOST LIKELY CAUSED BY POOR SAMPLE QUALITY, BUT THIS COULD NOT BE CONFIRMED AS ADDITIONAL INFORMATION WAS NOT PROVIDED. OTHER POSSIBLE ROOT CAUSES MAY BE RELATED TO THE INSTRUMENT AND AN ELECTROMAGNETIC INFLUENCE FROM THE ENVIRONMENT.

    Patients

    Seq Age Sex Outcome Treatment
    1