BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03685

    MDR report key: 4857236 · Received June 19, 2015

    Report

    Report Number
    1823260-2015-03685
    Event Type
    Malfunction
    Date Received
    June 19, 2015
    Date of Event
    June 7, 2015
    Report Date
    June 23, 2015
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. THE POSSIBLE ROOT CAUSES MAY BE RELATED TO PRE-ANALYTICS (E.G. IMPROPER MIXING/INVERSIONS OF PRIMARY TUBE OR TEMPORARY INSTRUMENT ISSUES SUCH AS DIRT FROM THE GRIPPER), BUT THIS COULD NOT BE CONFIRMED AS ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR TROPONIN T HS (HIGH SENSITIVE). THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TROPONIN T HS RESULT WAS 28.78 PG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THREE HOURS LATER A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS <3 PG/ML WITH A DATA FLAG. THE NEW SAMPLE WAS REPEATED TWICE AND BOTH RESULTS WERE <3 PG/ML WITH A DATA FLAG. THE ORIGINAL SAMPLE WAS MEASURED FROM A CUP AND REPEATED TWICE WITH RESULTS OF <3 PG/ML WITH A DATA FLAG AND <3 PG/ML WITH A DATA FLAG. NO ADVERSE EVENT OCCURRED. THE TROPONIN T HS (HIGH SENSITIVE) REAGENT LOT NUMBER WAS 181799. THE EXPIRATION DATE WAS NOT PROVIDED. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1