BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6017505 · Received October 11, 2016

    Report

    Report Number
    3007981285-2016-13900
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP BATTERY WAS AT 50% CHARGE WHEN THE PUMP BECAME UNRESPONSIVE AND STOPPED ALL INSULIN DELIVERY. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. MULTIPLE ATTEMPTS HAVE BEEN MADE BY TANDEM TECHNICAL SUPPORT TO FOLLOW UP WITH THE CUSTOMER TO COMPLETE TROUBLESHOOTING, HOWEVER NO RESPONSE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668084 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR