BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 9437855 · Received December 9, 2019

    Report

    Report Number
    3013756811-2019-90814
    Event Type
    Injury
    Date Received
    December 9, 2019
    Date of Event
    June 17, 2019
    Report Date
    December 9, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007318
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) LEVELS THAT RANGED BETWEEN 250-590 MG/DL AND WAS HOSPITALIZED; CAUSE WAS UNKNOWN. CUSTOMER RECEIVED AN INSULIN DRIP, FLUIDS, AND NAUSEA MEDICATION TO ADDRESS BG LEVELS. CUSTOMER WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2019 WITH NO PERMANENT DAMAGE. ADDITIONALLY, IT WAS REPORTED THAT THE BATTERY WAS DEPLETING QUICKLY. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER ON THE REPORTED ISSUE; HOWEVER, NO RESPONSE FROM THE CUSTOMER WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232445 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007318

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R