BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENULTIMATE

    MDR report key: 8894638 · Received August 13, 2019

    Report

    Report Number
    MW5089052
    Event Type
    Injury
    Date Received
    August 13, 2019
    Date of Event
    August 10, 2019
    Report Date
    August 10, 2019
    Manufacturer
    PHARMA TECH SOLUTIONS, INC.
    Product Code
    NBW
    UDI-DI
    00868906000131
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY HUSBANDS BLOOD SUGAR TEST STRIPS WORK IMPROPERLY LEADING TO THAT HE HAS TO USE 3 TO 5 TO GET A SINGLE GOOD BLOOD SUGAR READING. THEY WILL NOT ABSORB THE BLOOD. THE MFR IS PHARMATECH SOLUTIONS INC., (B)(4), PRODUCT NAME IS GENULTIMATE. LOT 9005A. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2019. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684524 GENULTIMATE SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW PHARMA TECH SOLUTIONS, INC. 9005A 00868906000131

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability