BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7363028 · Received March 22, 2018

    Report

    Report Number
    3013756811-2018-09772
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    March 2, 2018
    Report Date
    March 22, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS RAPIDLY DECREASING WITH A SLIGHT TRACE OF KETONES AND THE CUSTOMER WENT TO THE EMERGENCY ROOM (ER). REPORTEDLY, THE CUSTOMER'S BG WENT FROM 250-150 MG/DL WITHIN 45 MINUTES. THE CAUSE OF THE LOW BG LEVEL WAS UNKNOWN. WHILE IN THE ER, THE CUSTOMER HAD BLOOD WORK PERFORMED AND TREATED LOW BG WITH A SNICKERS BAR. AFTER A COUPLE OF HOURS IN THE ER, THE CUSTOMER LEFT FEELING LETHARGIC WITH A BG OF 134 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205243 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention INFUSION SET: AUTOSOFT 90, INSET 23''