BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6410917 · Received March 16, 2017

    Report

    Report Number
    3007981285-2017-07185
    Event Type
    Injury
    Date Received
    March 16, 2017
    Date of Event
    February 16, 2017
    Report Date
    March 16, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS (150-340 MG/DL). THE CUSTOMER CHANGED OUT THE INFUSION SET SITE MULTIPLE TIMES. INSULIN INJECTIONS AND BOLUS DELIVERIES WERE USED TO ADDRESS THE HIGH BG. THE CUSTOMER DID NOT KNOW THE CAUSE OF THE HIGH BG. A PUMP SYSTEM CHECK WAS PERFORMED AND NO DEVICE ISSUE WAS IDENTIFIED. THE CUSTOMER INCREASED THE BASAL DELIVERY TO 0.1 U/HR WITHOUT CHECK WITH A HEALTHCARE PROVIDER. TANDEM TECHNICAL SUPPORT ADVISED THE CUSTOMER TO DISCUSS THE BASAL SETTING AND HIGH BG EVENTS WITH A HEALTHCARE PROVIDER. THE CUSTOMER ACKNOWLEDGED THE ADVISE AND DECLINED FURTHER FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193046 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other INSULIN: NOVOLOG, INFUSION SET: T:90