BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7558210 · Received May 31, 2018

    Report

    Report Number
    3013756811-2018-18106
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 31, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED AND THE PUMP STOPPED ALL INSULIN DELIVERY. DURING TROUBLESHOOTING WITH TANDEM¿S TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED AND INSULIN DELIVERY WAS ABLE TO BE RESUMED. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE ALTITUDE ALARMS. REPORTEDLY, THE PUMP WAS SLIGHTLY WET AT THE TIME OF THE EVENT. THE CUSTOMER WAS ABLE TO SUCCESSFULLY CLOSE THE ALARM AND RESUME INSULIN DELIVERY SUCCESSFULLY. THE ISSUE WAS RESOLVED AFTER THE CUSTOMER LOADED A NEW CARTRIDGE. CUSTOMER ACKNOWLEDGED THAT THE ISSUE WAS DUE TO THE PUMP BEING EXPOSED TO CONDENSATION, HUMIDITY OR WATER. THE CUSTOMER'S BLOOD GLUCOSE WAS 150-221 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401099 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR