BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7357447 · Received March 21, 2018

    Report

    Report Number
    3013756811-2018-10113
    Event Type
    Malfunction
    Date Received
    March 21, 2018
    Date of Event
    March 4, 2018
    Report Date
    March 21, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM X2 G5 PUMP USER GUIDE STATES: YOUR T:SLIM X2 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 PRE-SET TO 12 HOURS. YOU CAN SET IT ANYWHERE BETWEEN 5 AND 24 HOURS, OR OFF. 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 CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER WAS INSTRUCTED TO PLUG THE PUMP INTO A POWER SOURCE FOR AT LEAST 30 MINUTES. CUSTOMER ACKNOWLEDGED. REPORTEDLY, THE ALERT HAD NOT REOCCURRED AFTER CHARGING THE PUMP. IN ADDITION, IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN AUTO-OFF ALARM. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER ON THE AUTO-OFF SAFETY FEATURE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 150-235 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200269 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR