BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEST NILE IGM EIA

    MDR report key: 4182063 · Received October 10, 2014

    Report

    Report Number
    MW5038631
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    October 1, 2013
    Report Date
    October 10, 2014
    Manufacturer
    FOCUS DIAFNOSTICS
    Product Code
    NOP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SINCE (B)(6) 2013, LABORATORIES BEGAN EXPERIENCING PROBLEMS WITH THE WEST NILE IGM EIA, SPECIFICALLY THAT THE KITS WOULD NOT PASS, THAT THE CALIBRATORS WERE OUT OF RANGE, HIGH. THE PRODUCT IS THE WEST NILE IGM EIA PRODUCED BY (B)(6), PRODUCT #EL0300M. WE HAVE SINCE LEARNED THAT MULTIPLE LABORATORIES WERE IMPACTED, THEY TOO, BEING TOLD THAT THEY WERE THE ONLY LABORATORY IMPACTED. SOME OF THE AFFECTED LABS DISCONTINUED TESTING. THERE WAS NO NOTIFICATION TO THE USERS OF THIS PRODUCT. I CANNOT SAY MORE BECAUSE I WAS INSTRUCTED NOT TO CONTACT YOU, BUT I BELIEVE THE APPEARANCE OF POSSIBLE INTENTIONAL DECEIT ON THE PART OF THE MFR REQUIRES THAT I CONTACT YOU, THAT I AM ETHICALLY BOUND TO NOTIFY YOU, EVEN AT THIS LATER DATE. THE PROBLEM AS FAR AS WE KNOW WAS, AND MAYBE STILL IS, ONGOING. DATES OF USE: 10/01/2013-10/10/2014. DIAGNOSIS OR REASON FOR USE: FOR TREATMENT OF WEST NILE PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637865 WEST NILE IGM EIA NONE NOP FOCUS DIAFNOSTICS EL0300M MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention