BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-04555

    MDR report key: 5225680 · Received November 16, 2015

    Report

    Report Number
    1823260-2015-04555
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    November 2, 2015
    Report Date
    November 17, 2015
    PMA / PMN Number
    K100853
    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

    BASED ON A REVIEW OF THE ALARM TRACE THERE IS NO INDICATION OF AN ISSUE. QUALITY CONTROLS WERE ACCEPTABLE. THE FIELD SERVICE ENGINEER CHECKED VARIOUS PARTS OF THE INSTRUMENT, MADE ADJUSTMENTS AND CHANGED THE MEASURING CELL. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. A POSSIBLE ROOT CAUSE MAY BE RELATED TO IMPROPER SAMPLE HANDLING DUE TO THE SHORT CENTRIFUGATION TIME. A GENERAL INSTRUMENT ISSUE CANNOT BE EXCLUDED.

    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 RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT PRESENTED TO THE CARDIOLOGY INTENSIVE CARE UNIT ON (B)(6) 2015. UPON ARRIVAL, THE PATIENT'S TROPONIN T HS RESULT WAS 1300 NG/L. DURING THE DAY, THE PATIENT'S TROPONIN T HS RESULT INCREASED TO 12,000 NG/L. LATER THAT NIGHT THE PATIENT'S TROPONIN T HS RESULT WAS 37.21 NG/L. SINCE THIS RESULT WAS NOT CONSISTENT WITH THE CLINICAL STATUS OF THE PATIENT AND THE PRIOR RESULTS, THE LABORATORY TECHNICIAN REPEATED THE SAMPLE AND THE RESULT WAS 3829 NG/L. NO ADVERSE EVENT OCCURRED. THE PATIENT IS LISTED AS BEING FINE. THE TROPONIN T HS REAGENT LOT NUMBER WAS 181799. THE EXPIRATION DATE WAS NOT PROVIDED. IT WAS NOTED THAT THE CENTRIFUGATION TIME WAS TOO SHORT. THE LABORATORY CENTRIFUGATION TIME WAS 10 MINUTES. THE MANUFACTURER'S RECOMMENDED TIME IS 15 MINUTES. IT WAS ALSO NOTED THAT THE LAST CALIBRATION ON REAGENT LOT 181799 WAS PERFORMED ON (B)(6) 2015. THIS IS NOT WITHIN THE RECOMMENDED TIMEFRAME ACCORDING TO PRODUCT LABELING.

    Patients

    Seq Age Sex Outcome Treatment
    1 043 YR