BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTICARE SAFETY INSULIN SYRINGE

    MDR report key: 5500091 · Received March 10, 2016

    Report

    Report Number
    MW5060893
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Date of Event
    March 9, 2016
    Report Date
    March 10, 2016
    Manufacturer
    ULTI-MED INTL., INC.
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    WHILE PREPARING INSULIN DOSE FOR MY CHILD, I NOTICED THAT THE ZERO MARK ON THE SYRINGE WAS WAY PAST ONE UNIT MARK. I NOTICED THIS AFTER THE BOX OF SYRINGES WERE NEARLY DONE. THIS MAY HAVE CAUSED MY DAUGHTER TO RECEIVE LITTLE TO NO INSULIN AT TIMES BECAUSE HER USUAL DOSAGE IS ONE UNIT OF INSULIN. THERE HAVE BEEN DAYS OVER THE PAST FEW WEEKS WHERE HER BLOOD GLUCOSE LEVEL WAS ELEVATED WHEN HER NEXT DOSE WAS DUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150040 ULTICARE SAFETY INSULIN SYRINGE INSULIN SYRINGES MEG ULTI-MED INTL., INC. A51007

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other