BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA FLU A/B AND RSV DIRECT ASSAY

    MDR report key: 4379435 · Received December 29, 2014

    Report

    Report Number
    2023365-2014-00052
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    FOCUS DIAGNOSTICS, INC.
    Product Code
    OCC
    PMA / PMN Number
    K120413
    Removal / Correction Number
    Z-1958-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AT ROOM TEMPERATURE AND COULD NOT BE USED FOR TESTING. THE REVIEW OF THE RUN DATA INDICATED THAT THE QC FAILURE WAS DUE TO A POSSIBLE DISC STORAGE ISSUE. INVESTIGATION DETERMINED THAT CARRY-OVER CONTAMINATION FROM SUCCESSIVE RUNS CAN OCCUR IF THE END-USER STORES THE DAD (DIRECT AMPLIFICATION DISC) VERTICALLY (I.E. ON EDGE). STORAGE OF THE DAD IN ANY VERTICAL POSITION AFTER INITIAL USE HAS A POTENTIAL OF ALLOWING FLUID TO TRAVEL BACK THROUGH THE CHANNELS AND CONTAMINATE OTHER UNUSED WEDGES. THIS MAY RESULT IN OBTAINING FALSE POSITIVE RESULTS. THE PRODUCT INSERT WARNING AND PRECAUTIONS SECTION HAS BEEN REVISED TO INCLUDE THE FOLLOWING ITEM: "AFTER EACH USE STORE DAD DISCS FLAT WITH THE NUMBERED FOIL SIDE UP." (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED A NEW LOT OF KITS AND THEY ARE NOT PASSING QC. THE POSITIVE CONTROL FAILED FOR BOTH RUNS AND THE CUSTOMER WAS UNABLE TO OBTAIN READINGS. NO RESULTS WERE REPORTED TO THE PHYSICIAN. THE PRODUCT INSERT WAS REVISED TO ADVISE THE END-USER THAT "AFTER EACH USE DAD DISCS FLAT WITH THE NUMBERED FOIL SIDE UP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854602 SIMPLEXA FLU A/B AND RSV DIRECT ASSAY IN-VITRO-DIAGNOSTIC TEST, INFLUENZA OCC FOCUS DIAGNOSTICS, INC. MOL2650 24797

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK