BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACK

    MDR report key: 5482771 · Received March 6, 2016

    Report

    Report Number
    2023365-2016-00018
    Event Type
    Malfunction
    Date Received
    March 6, 2016
    Date of Event
    January 28, 2016
    Report Date
    March 4, 2016
    Manufacturer
    FOCUS DIAGNOSTICS
    Product Code
    OQO
    PMA / PMN Number
    K150962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOCUS DIAGNOSTICS HAS RECEIVED A TOTAL OF (B)(4) COMPLAINTS FROM 20 CUSTOMERS FOR EARLY CYCLE THRESHOLD (CT) ISSUES WITH THE DIRECT AMPLIFICATION DISC (DAD) (MOL1455, MOL1451, AND MOL 1452) WHILE PERFORMING THE SIMPLEXA HSV 1 & 2 DIRECT ASSAY. THIS ERROR MAY RESULT IN A FALSE POSITIVE RESULT, A FALSE NEGATIVE RESULT, AND ERROR CODE(S) GIVING AN INVALID RUN. EARLY INTERNAL TESTING REPRODUCED THE EARLY CT THRESHOLD; HOWEVER, THESE EARLY CT WERE PRODUCED ONLY WHEN THE DAD WAS USED AFTER A PREVIOUS PARTIAL RUN. THE FALSE POSITIVE RESULT WAS NOT REPORTED TO THE DOCTOR. THERE WAS NO PATIENT INVOLVEMENT. A VOLUNTARY RECALL HAS BEEN PERFORMED RELATED TO THE REPORTED LOT. AS OF MARCH 4, 2016, THERE HAS BEEN NO REPORT OF PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138819 SIMPLEXA HSV 1 & 2 DIRECT, SIMPLEXA HSV 1 & 2 POSITIVE CONTROL PACK HERPES SIMPLEX VIRUS NUCLEIC ACID AMPLIFICATION ASSAY OQO FOCUS DIAGNOSTICS MOL2150 29064

    Patients

    Seq Age Sex Outcome Treatment
    1