BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA FLU A/B AND RSV DIRECT ASSAY

    MDR report key: 4379452 · Received December 29, 2014

    Report

    Report Number
    2023365-2014-00043
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 2014
    Manufacturer
    FOCUS DIAGNOSTICS, INC.
    Product Code
    OCC
    PMA / PMN Number
    K120413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO MORE SAMPLES (PATIENT SPECIMEN OR REACTION MIX) THAT COULD BE RETURNED FOR TESTING. A RETAIN SAMPLE FROM THE REPORTED LOT (LN 24160) WAS TESTED, EIGHT REPLICATES PER HOUR OF REACTION MIX PRODUCTION (5 HOURS FOR 40 TOTAL REPLICATES) WERE ASSAYED WITH NO-TEMPLATE CONTROL ACCORDING THE INSTRUCTIONS IN THE PRODUCT INSERT. NO FALSE POSITIVE RESULTS WERE OBSERVED. ONE HUNDRED PERCENT OF THE NTC REPLICATES WERE NEGATIVE FOR ALL ANALYTES AND THE RNA INTERNAL CONTROL WAS DETECTED. NO PROBLEMS WERE OBSERVED DURING TESTING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE HAD THREE FALSE POSITIVE RESULTS. SUBSEQUENT INFORMATION STATED THAT THERE WERE 6 SAMPLES THAT TESTED POSITIVE AND THEN CAME UP NEGATIVE. THEY SENT THE POSITIVE SAMPLES TO THEIR LOCAL PUBLIC HEALTH LABORATORY AND THE PUBLIC HEALTH LAB FOUND THE SAMPLES TO BE NEGATIVE. THE STATE LAB PERFORMED A MOLECULAR METHOD (RT-PCR) FOR CONFIRMATION AND STATED THAT IT IS A MODIFIED FDA TEST. THE LABORATORY REPORTED THE FALSE POSITIVE RESULTS TO THE DOCTOR. THIS SUPPLEMENTAL MDR IS FOR THE FIFTH OF THE SIX FALSE POSITIVE RESULTS THAT WERE REPORTED TO THE DOCTOR. FIVE ADDITIONAL MDRS ARE BEING SUBMITTED REMAINING EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854892 SIMPLEXA FLU A/B AND RSV DIRECT ASSAY IN-VITRO-DIAGNOSTIC TEST, INFLUENZA OCC FOCUS DIAGNOSTICS, INC. MOL2650 24160

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK