BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6082170 · Received November 7, 2016

    Report

    Report Number
    3007981285-2016-17542
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 15, 2016
    Report Date
    October 15, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 OCCLUSION ALARMS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 163-213 MG/DL. A SYSTEM CHECK SHOWED THAT THE OCCLUSION MAY BE AT THE SITE LEVEL; HOWEVER, AFTER CHANGING THE SUPPLIES THE CUSTOMER RECEIVED ANOTHER OCCLUSION. THE CARTRIDGE AND TUBING WERE FOUND TO BE FUNCTIONING AS EXPECTED AND THE CANNULA SHOWED NO DAMAGE. THE CUSTOMER WAS TO CHANGE THE TYPE OF INFUSION SET USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732647 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR INSULIN: HUMALOG, INFUSION SET: CONTACT DETACH