BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6034140 · Received October 17, 2016

    Report

    Report Number
    3007981285-2016-14287
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 24, 2016
    Report Date
    September 24, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CONTACT THAT THE CUSTOMER RECEIVED MULTIPLE, INTERMITTENT OCCLUSION ALARMS. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 212- 228 MG/DL AND A BOLUS OF INSULIN WAS DELIVERED TO ADDRESS THE BG LEVEL. THE CONTACT HAD CHANGED THE SUPPLIES ON THE PUMP AFTER THE FIRST OCCLUSION. A SYSTEM CHECK USING THE CURRENT SUPPLIES FOUND THE CARTRIDGE AND INFUSION SET TUBING TO BE FUNCTIONING AS INTENDED. NO ISSUE WAS OBSERVED WITH THE CANNULA. THE CONTACT THOUGHT THAT THE PUMP WAS THE CAUSE OF THE OCCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685671 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR INFUSION SET, T:90, INSULIN: NOVOLOG