BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6141061 · Received December 2, 2016

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    Report

    Report Number
    3007981285-2016-22317
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 11, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CARTRIDGE ALARM 19 WITH A CARTRIDGE DURING BASAL DELIVERY. CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 254 MG/DL. REPORTEDLY, THE BG LEVEL WAS ADDRESSED BY THE CUSTOMER LOADING A NEW CARTRIDGE AND RESUMING INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793321 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other INFUSION SET: INSET, INSULIN: HUMALOG