BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6028725 · Received October 13, 2016

    Report

    Report Number
    3007981285-2016-13490
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    September 14, 2016
    Report Date
    September 21, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 BY THE CONTACT THAT THE CUSTOMER RECEIVED MULTIPLE, INTERMITTENT OCCLUSION ALARMS. THE CONTACT THOUGHT THAT THE PUMP WAS BROKEN. AFTER THE MOST RECENT OCCLUSION ALARMS, THE CUSTOMER CHANGED THE INFUSION SET AND CARTRIDGE MULTIPLE TIMES. THE CUSTOMER DISCONNECTED FROM THE PUMP. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 600 MG/DL WITH A LARGE LEVEL OF KETONES AND INSULIN INJECTIONS WERE USED TO ADDRESS THE BG LEVEL. A CAUSE OF THE PAST OCCLUSIONS COULD NOT BE DETERMINED. A SYSTEM CHECK WAS PERFORMED USING THE CURRENT SUPPLIES ON THE PUMP. THE PUMP AND INFUSION SET TUBING WERE FOUND TO BE OPERATING AS EXPECTED. THERE WAS NO DAMAGE NOTED TO THE CANNULA. THE CUSTOMER CHANGED THE SUPPLIES AGAIN AND NO ADDITIONAL OCCLUSION ALARM HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678185 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M015568

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other INSULIN: HUMALOG, INFUSION SET: INSET