BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-04499

    MDR report key: 5213649 · Received November 10, 2015

    Report

    Report Number
    1823260-2015-04499
    Event Type
    Malfunction
    Date Received
    November 10, 2015
    Date of Event
    October 20, 2015
    Report Date
    December 2, 2015
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF THE ALARM TRACE, THERE IS NO INDICATION OF AN INSTRUMENT ISSUE AT THE TIME OF THE ERRONEOUS RESULTS. CALIBRATION AND QUALITY CONTROLS WERE ACCEPTABLE. THE ANALYZER PERFORMANCE CHECK WAS ACCEPTABLE. A POSSIBLE ROOT CAUSE MAY BE RELATED TO ELECTROMAGNETIC INTERFERENCE AS THE COUNT DIFFERENCES ARE LOW AND THERE ARE 5 CENTRIFUGES LOCATED DIRECTLY NEXT TO THE INSTRUMENT.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER PROVIDED PHOTOS SHOWING WHERE THE LABORATORY CENTRIFUGES ARE POSITIONED IN RELATION TO THE E 601 ANALYZER. A POSSIBLE ROOT CAUSE MAY BE AN ELECTROMAGNETIC INTERFERENCE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED RESULTS FROM 2 SAMPLES FOR ONE PATIENT IN THE EMERGENCY ROOM WHO WAS TESTED FOR TROPONIN T HS (HIGH SENSITIVE) TROPONIN T HS. OF THE DATA PROVIDED, THE RESULTS FOR ONE SAMPLE WERE ERRONEOUS AND REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TROPONIN T HS RESULT AT 11:25 A.M. WAS 24.76 NG/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. A 2ND SAMPLE WAS OBTAINED AT 4:22 P.M. AND THE RESULT WAS 5.61 NG/L. AT THIS POINT, THE LABORATORY TECHNICIAN DECIDED TO REPEAT BOTH SAMPLES. THE INITIAL SAMPLE WAS REPEATED AT 5:33 P.M. AND THE RESULT WAS 3.95 NG/L. THE 2ND SAMPLE WAS REPEATED AT 5:21 P.M. AND THE RESULT WAS 5.67 NG/L. THE REPEAT RESULTS WERE CONSIDERED TO BE CORRECT. NO ADVERSE EVENT OCCURRED. THE TROPONIN T HS REAGENT LOT NUMBER WAS 181799. THE EXPIRATION DATE WAS NOT PROVIDED.

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR