BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-01826

    MDR report key: 6823445 · Received August 28, 2017

    Report

    Report Number
    1823260-2017-01826
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    April 1, 2017
    Report Date
    August 28, 2017
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE HIGH TROPONIN T HS RESULTS FOR TWO PATIENT SAMPLES. BOTH PATIENTS WERE CARDIAC PATIENTS. PATIENT 1 INITIAL RESULT WAS AT 11:30 WAS 321 NG/L. A NEW SAMPLE DRAWN AT 16:00 HAD A RESULT OF 12 NG/L. BOTH SAMPLES WERE REPEATED AND THE RESULT FOR EACH WAS 12 NG/L. THIS EVENT OCCURRED IN (B)(6), BUT A SPECIFIC DATE COULD NOT BE PROVIDED. PATIENT 2 INITIAL RESULT AT 15:00 WAS 616 NG/L. A NEW SAMPLE DRAWN AT 18:00 AND THE RESULT WAS 17 NG/L. BOTH SAMPLES WERE REPEATED AND THE RESULT FOR EACH WAS 17 NG/L ON DIFFERENT ANALYZERS. THIS EVENT OCCURRED IN (B)(6), BUT A SPECIFIC DATE COULD NOT BE PROVIDED. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER IN USE IN (B)(6) WAS 182603 AND IN (B)(6) WAS 245180. THE EXPIRATION DATES WERE REQUESTED BUT WERE NOT PROVIDED. FOR PATIENT 1, IT WAS CONFIRMED THERE WAS NO CLOT OR FIBRIN IN THE SAMPLE. THE CUSTOMER REPEATED MANY TROPONIN T SAMPLES THAT WERE ORIGINALLY TESTED BEFORE AND AFTER THE EVENTS. ALL OF THESE SAMPLES GAVE THE SAME RESULT UPON REPETITION. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE RESPONSE FROM THE CUSTOMER, THE ISSUE WAS RESOLVED WITHOUT ANY ACTION. THE ANALYZER ALARMS TRACE PROVIDED DID NOT INDICATE ANY ISSUES THEREFORE A HARDWARE ISSUE WAS UNLIKELY. A POSSIBLE ROOT CAUSE SAMPLE MATERIAL COLLECTING ON THE INCUBATOR OR THE PROBE. THIS COULD OBSTRUCT THE FLOW PATH OR CONTAMINATE SAMPLES.

    Patients

    Seq Age Sex Outcome Treatment
    1