BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-03973

    MDR report key: 5004799 · Received August 14, 2015

    Report

    Report Number
    1823260-2015-03973
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 27, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE TROPONIN T HS REAGENT LOT NUMBER WAS 181799. THE FIELD SERVICE ENGINEER INDICATED THE MAINTENANCE STATUS OF THE ANALYZER WAS ACCEPTABLE. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT OR INSTRUMENT ISSUE IS NOT LIKELY. A POSSIBLE ROOT CAUSE MAY BE RELATED TO PRE-ANALYTICAL ISSUES. A POSSIBLE ELECTROMAGNETIC INTERFERENCE CANNOT BE EXCLUDED AS THERE ARE 2 CENTRIFUGES PLACED NEAR THE ANALYZER.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN ERRONEOUS HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR TROPONIN T HS (HIGH SENSITIVE) TROPONIN T HS BETWEEN 2 E601 ANALYZERS. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TROPONIN T HS RESULT ON THE FIRST E601 ANALYZER WAS 47.69 PG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2015 REPEAT TESTING WAS PERFORMED ON A 2ND E601 ANALYZER AND THE RESULTS WERE 9.95 PG/ML AND 9.97 PG/ML. THE PATIENT IS CURRENTLY HOSPITALIZED IN THE FIRST AID UNIT. NO ADVERSE EVENT DUE TO THE DEVICE HAS BEEN REPORTED. THE TROPONIN T HS REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER CHECKED THE EXTRA WASH SYSTEM OF THE ANALYZER AND FOUND A SMALL "BALL" OF DUST.

    Patients

    Seq Age Sex Outcome Treatment
    1 079 YR