BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4843967 · Received June 12, 2015

    Report

    Report Number
    3007981285-2015-34945
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN REC'D. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS REC'D.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CUSTOMER WOKE UP IN THE MORNING, THE PUMP WAS NOTED TO HAVE SHUT OFF DURING THE NIGHT. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, REVIEW OF THE PUMP DATA REVEALED LOW POWER ALERTS AND A LOW POWER ALARM, WHICH WERE NOT ADDRESSED BY THE CUSTOMER. HOWEVER, THE CUSTOMER REPORTED THAT THE PUMP HAD 60% BATTERY LIFE, PRIOR TO THE CUSTOMER GOING TO SLEEP, AND THAT THE PUMP HAD SHUT OFF UNEXPECTEDLY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 193 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383607 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR