BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 11014989 · Received December 15, 2020

    Report

    Report Number
    3013756811-2020-146001
    Event Type
    Malfunction
    Date Received
    December 15, 2020
    Date of Event
    December 4, 2020
    Report Date
    December 15, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007318
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE TANDEM USER GUIDE: ALWAYS MAKE SURE THAT THE CORRECT TIME AND DATE ARE SET ON YOUR SYSTEM. WHEN EDITING TIME, ALWAYS CHECK THAT THE AM/PM SETTING IS ACCURATE. AM IS TO BE USED FROM MIDNIGHT UNTIL 11:59 AM. PM IS TO BE USED FROM NOON UNTIL 11:59 PM. NOT HAVING THE CORRECT TIME AND DATE SETTING MAY AFFECT SAFE INSULIN DELIVERY. 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 TIME WAS INCORRECT DUE TO NOT HAVING BEEN ADJUSTED FOR DAYLIGHT SAVING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS BETWEEN 170-321 MG/DL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER CORRECTED THE TIME AND RESUMED INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474765 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000354 00853052007318

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR INFUSION SET: AUTOSOFT 90INSULIN: NOVOLOG