BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA FLU A/B AND RSV DIRECT ASSAY

    MDR report key: 4379439 · Received December 29, 2014

    Report

    Report Number
    2023365-2014-00046
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    November 1, 2013
    Report Date
    November 1, 2013
    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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 RAN A SAMPLE AND IT CAME UP POSITIVE FOR FLU A AND FLU B. UPON RETEST, THE SAMPLE WAS NEGATIVE FOR BOTH FLU STRAINS. THE DATA PROFILE HAD AN UNUSUAL CURVE. THE POSITIVE RESULTS WERE REPORTED TO THE DOCTOR. THE PRODUCT INSERT WAS REVISED TO ADVISE THE END-USER THAT "AFTER EACH ONE STORE DAD DISCS FLAT WITH THE NUMBERED FOIL SIDE UP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854716 SIMPLEXA FLU A/B AND RSV DIRECT ASSAY IN-VITRO-DIAGNOSTIC TEST, INFLUENZA OCC FOCUS DIAGNOSTICS, INC. MOL2650 23784

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK