BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFETEC ELITE V1.0

    MDR report key: 5834734 · Received July 29, 2016

    Report

    Report Number
    2435501-2016-00001
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    May 19, 2016
    Report Date
    July 29, 2016
    Manufacturer
    IT SYNERGISTICS, LLC
    Product Code
    MMH
    PMA / PMN Number
    BK060032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ON 6/02/2016 IT SYNERGISTICS, (HEREIN AFTER ITSY) WAS MADE AWARE OF AN ISSUE FROM CUSTOMER (B)(6), WHERE THE LIFETEC ELITE V1.0 510(K) BK060032 DID NOT APPLY A PRODUCT LEVEL LAB HOLD ON A UNIT OF BLOOD ON (B)(6) 2016 THAT HAD AN ASSOCIATED POSITIVE TEST RESULT, WHICH ALLOWED THE SUSPECT PRODUCT TO BE SOLD. IT HAS BEEN DETERMINED THAT THE INITIAL POSITIVE LABORATORY TEST WAS CONFIRMED NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487002 LIFETEC ELITE V1.0 LIFETEC ELITE MMH IT SYNERGISTICS, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1