BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6691400 · Received July 6, 2017

    Report

    Report Number
    3007981285-2017-18864
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    June 13, 2017
    Report Date
    July 6, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM USER GUIDE STATES: TANDEM DIABETES CARE, INC. RECOMMENDS PERIODICALLY CHECKING THE BATTERY LEVEL INDICATOR, CHARGING THE PUMP FOR A SHORT PERIOD OF TIME EVERY DAY (10 TO 15 MINUTES), AND ALSO AVOIDING FREQUENT FULL DISCHARGES. 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 THE PUMP SCREEN HAD GONE BLANK AND THE LED LIGHT WAS NOT BLINKING. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 329 MG/DL. THE SCHOOL NURSE THOUGHT THAT THE BATTERY WAS NOT CHARGED AND PLUGGED THE PUMP IN TO CHARGE. THE PUMP STARTED TO CHARGE. THE CONTACT REVIEWED THE PUMP HISTORY AND LOW POWER ALERTS WERE FOUND PRIOR TO THE PUMP SHUTDOWN AND RESET ALARMS. THE PUMP HAD SHUTDOWN DUE TO A LOW BATTERY. TANDEM TECHNICAL SUPPORT ASSISTED THE CONTACT WITH RELOADING THE CARTRIDGE AND RESUMING INSULIN DELIVERY. THE SCHOOL NURSE ASSISTED THE CUSTOMER WITH ADMINISTERING A BOLUS OF INSULIN. IT WAS "NORMAL" FOR THE SCHOOL NURSE TO ASSIST THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471500 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention