BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6149214 · Received December 6, 2016

    Report

    Report Number
    3007981285-2016-22632
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 14, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 MULTIPLE, INTERMITTENT OCCLUSION ALARMS. REPORTEDLY, THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM THE 200-400'S (MG/DL) WITH SMALL TO MODERATE LEVEL OF KETONES. THE CUSTOMER WAS UNSURE IF HEALTH CARE PROVIDER (HCP) WOULD CONSIDER THE LEVEL OF KETONES TO BE LIFE THREATENING; HOWEVER, THE CUSTOMER STATED THE KETONE LEVEL WAS DANGEROUS. TO ADDRESS BG LEVEL, THE CUSTOMER DELIVERED A CORRECTION BOLUS VIA THE PUMP, CONSUMED WATER, AND CONSULTED WITH HCP. AS THE OCCLUSIONS HAD OCCURRED IN THE PAST, TANDEM TECHNICAL SUPPORT WAS UNABLE TO TROUBLESHOOT TO DETERMINE A POSSIBLE CAUSE OF THE OCCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798639 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other INSULIN: NOVOLOG