BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 7872994 · Received September 13, 2018

    Report

    Report Number
    3013756811-2018-32233
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    August 25, 2018
    Report Date
    September 13, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004781512673
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE USER GUIDE: DO NOT REUSE CARTRIDGES OR USE CARTRIDGES OTHER THAN THOSE MANUFACTURED BY TANDEM DIABETES CARE, INC. USE OF CARTRIDGES NOT MANUFACTURED BY TANDEM DIABETES CARE, INC. OR REUSE OF CARTRIDGES MAY RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. THIS CAN CAUSE VERY LOW OR VERY HIGH BLOOD GLUCOSE. 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 CARTRIDGE (ALARM 1) OCCURRED. BLOOD GLUCOSE WAS 70-300 MG/DL. CUSTOMER RELOADED THE SAME CARTRIDGE. CUSTOMER WAS AWARE THAT THE CARTRIDGE WAS LABELED FOR SINGLE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716100 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096 M021737 00852162004781512673

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR