BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC QUICK-SET

    MDR report key: 6085330 · Received November 4, 2016

    Report

    Report Number
    MW5065869
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 4, 2016
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TUBING ON INSULIN DELIVERY INFUSION SET DETACHED FROM SET WHERE INSULIN IS INFUSED INTO THE BODY. THIS CAUSED A FAILURE OF INSULIN TO BE INFUSED INTO MY BODY RESULTING IN AN ELEVATED BLOOD GLUCOSE. FORTUNATELY MY CONTINUOUS GLUCOSE MONITOR ALERTED ME TO MY RISING BLOOD GLUCOSE ALLOWING ME TO EVALUATE AND CORRECT WITH AN INJECTION. NEW SET TUBING WAS INSTALLED AND BLOOD GLUCOSE CONTROL WAS SUCCESSFULLY IMPLEMENTED. I HAVE REPORTED THIS TO THE MFR AND THEY ADVISED THEY HAVE HAD OTHER REPORTS OF LOOSE TUBING. THEY WERE ADVISED THAT I WOULD BE REPORTING THIS TO THE FDA. LEGAL MFR: UNOMEDICAL (B)(4). DISTRIBUTOR: (B)(4), PRODUCT MEDTRONIC QUICK-SET REF #MMT-393, LOT #5122421, EXP: 10/2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730870 MEDTRONIC QUICK-SET MEDTRONIC QUICK-SET FPA UNOMEDICAL A/S MMT-393 5122421

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR INSULIN INFUSED VIA| PUMP