BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6645558 · Received June 15, 2017

    Report

    Report Number
    3007981285-2017-16548
    Event Type
    Injury
    Date Received
    June 15, 2017
    Date of Event
    May 26, 2017
    Report Date
    June 15, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING INTERMITTENT ELEVATED BLOOD GLUCOSE (BG) LEVELS FOR THE PAST FEW DAYS FROM 250-350 (MG/DL). REPORTEDLY, THE CAUSE OF THE ELEVATED BG LEVELS IS UNKNOWN. A BOLUSES VIA THE PUMP WERE USED TO ADDRESS BG LEVELS. FOLLOW UP WITH THE CUSTOMER CONFIRMED THE CUSTOMER'S BG LEVEL HAD LOWERED TO 192 (MG/DL). REPORTEDLY THE CUSTOMER WOULD CONTINUE TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425302 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other