BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 10092294 · Received May 27, 2020

    Report

    Report Number
    3013756811-2020-51067
    Event Type
    Malfunction
    Date Received
    May 27, 2020
    Date of Event
    March 24, 2020
    Report Date
    May 27, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    852162004439
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER GUIDE STATES: YOUR T:SLIM PUMP CAN STOP INSULIN DELIVERY AND ALERT YOU (OR WHOEVER IS WITH YOU) IF THERE HAS BEEN NO INTERACTION WITH THE PUMP WITHIN A SPECIFIED PERIOD OF TIME. THE DEFAULT FOR THIS ALARM IS PRESET TO 12 HOURS. YOU CAN SET IT ANYWHERE BETWEEN 5 AND 24 HOURS, OR OFF. THIS ALARM NOTIFIES YOU THAT THERE HAS BEEN NO INTERACTION WITH THE PUMP IN THE SPECIFIED NUMBER OF HOURS AND THE PUMP WILL SHUT DOWN AFTER 30 SECONDS. 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 AN AUTO-OFF ALARM OCCURRED. CUSTOMER CONFIRMED THAT THERE HAD BEEN NO INTERACTION WITH THE PUMP FOR AN EXTENDED PERIOD. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER ON THE PUMP'S AUTO-OFF SAFETY FEATURE PER USER GUIDE AND ASSISTED THE CUSTOMER WITH ADJUSTING THE AUTO-OFF SAFETY FEATURE TO ADDRESS THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 211-388 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558079 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003 852162004439

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR