BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-04428

    MDR report key: 5194421 · Received November 2, 2015

    Report

    Report Number
    1823260-2015-04428
    Event Type
    Malfunction
    Date Received
    November 2, 2015
    Date of Event
    October 11, 2015
    Report Date
    November 2, 2015
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 DETERMINED BASED ON THE PROVIDED INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR TROPONIN T HS (HIGH SENSITIVE) - TNT HS. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 18.21 NG/L. THE OPERATOR NOTED THAT A PREVIOUS SAMPLE FROM THIS PATIENT HAD A VALUE OF > 1000 NG/L. THE SAMPLE IN QUESTION WAS THEN REPEATED ON A DIFFERENT COBAS 8000 ANALYZER, RESULTING AS 1104 NG/L. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TNT HS REAGENT LOT NUMBER WAS 181799. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1 062 YR