BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 8069460 · Received November 14, 2018

    Report

    Report Number
    3013756811-2018-40950
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 14, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004521
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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 A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING, CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM AND RESUME INSULIN DELIVERIES. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED BETWEEN 110-322 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910136 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004521

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR