BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA FLU A/B AND RSV DIRECT ASSAY

    MDR report key: 4379437 · Received December 29, 2014

    Report

    Report Number
    2023365-2014-00050
    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 CUSTOMER REPORTED THE EVENT AGAINST CATALOG # MOL1451, THE DIRECT AMPLIFICATION DISK, WHICH IS USED WITH MOL2650. THE LOT NUMBER OF THE MOL1451 PRODUCT WAS REPORTED AS LOT# 132222. THERE IS NO EXPIRATION DATE FOR DAD DISKS. THE MFR DATE OF THE DAD DISC WAS ON (B)(6) 2013. 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". MFR. REF. NUMBER #:(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY BELIEVE THAT THEY HAVE A FLU A AMPLICON ISSUE, POSSIBLY RELATED TO REUSING THE DAD DISCS. THE CUSTOMER TOOK ENVIRONMENTAL SWABS FROM VARIOUS AREAS AROUND THEIR LABORATORY. THE SWABS FROM ALL THREE OF THEIR CYCLERS CAME UP POSITIVE FOR FLU A. THEY HAVE NOT FOUND ANY OTHER AREAS OF CONTAMINATION IN THEIR LABORATORY. THEY STORE THE DAD DISCS VERTICALLY IN-BETWEEN USES. THE CUSTOMER DID NOT FEEL THAT THIS WAS AFFECTING THE PT RESULTS. THE RESULTS WERE NOT REPORTED TO THE DOCTOR. THE PRODUCT INSERT WAS REVISED TO ADVISE THE END-USER THAT "AFTER EACH USE STORE DAD DISCS FLAT WITH THE NUMBERED FOIL SIDE UP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855159 SIMPLEXA FLU A/B AND RSV DIRECT ASSAY IN-VITRO-DIAGNOSTICS TEST, INFLUENZA OCC FOCUS DIAGNOSTICS, INC. MOL2650 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK