BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MW5072515

    MDR report key: 6900165 · Received September 27, 2017

    Report

    Report Number
    MW5072515
    Event Type
    Malfunction
    Date Received
    September 27, 2017
    Date of Event
    February 9, 2017
    Report Date
    May 15, 2017
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERFORMING A PROFICIENCY TESTING MLE M1 SPECIMEN RS-1 FOR STREPTOCOCCUS A. WE HAD A NEGATIVE RESULT UPON COMPLETION OF THE TEST. WHEN WE RECEIVED OUR PROFICIENCY TESTING BACK FROM MLE, THEY REPORT THAT THE RESULT SHOULD HAVE BEEN POSITIVE. WAS SOMEONE OPERATING THE MEDICAL DEVICE WHEN THE PROBLEM OCCURRED: YES. IF YES, WHO WAS USING IT: A HEALTH PROFESSIONAL.

    Patients

    Seq Age Sex Outcome Treatment
    1