BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6001791 · Received October 5, 2016

    Report

    Report Number
    3007981285-2016-13612
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 BY THE CUSTOMER THAT THE BOLUS REQUEST TO BE DELIVERED WAS TOO HIGH AND THE CUSTOMER WAS UNSURE OF THE REASON. REPORTEDLY, THE CUSTOMER ENTERED A BOLUS REQUEST OF 30 GRAMS OF CARBOHYDRATES AND A BLOOD GLUCOSE (BG) VALUE OF 220 MG/DL AND RECEIVED A CALCULATION OF 21.67 UNITS OF INSULIN DELIVERED. REVIEW OF THE CUSTOMER'S PROFILE WITH TANDEM TECHNICAL SUPPORT SHOWED THAT THE CARBOHYDRATE RATIO WAS SET TO 1:1.5GRAMS, AND THE CUSTOMER BELIEVED THAT THE SETTING SHOULD REFLECT 1:15GRAMS. THE CUSTOMER CONFIRMED THAT THE HEALTH CARE PROVIDER (HCP) WOULD BE CONSULTED REGARDING THE SETTINGS. SEVERAL HOURS LATER, DURING A FOLLOW-UP CALL, THE CUSTOMER REPORTED THAT THE CLINICAL DIABETES EDUCATOR (CDE) CONFIRMED THAT THE CARBOHYDRATE RATIO OF 1:1.5GRAMS WAS CORRECT. THE CUSTOMER REPORTED BEING SURE THAT 21.67 UNITS OF INSULIN WAS TOO MUCH INSULIN, AND INDICATED SLIDING SCALE THERAPY WOULD BE USED FOR DIABETES MANAGEMENT. THE CUSTOMER CONFIRMED HCP WOULD BE CONSULTED TO DISCUSS SETTINGS AND THAT THE CUSTOMER WOULD CALL BACK TANDEM TECHNICAL SUPPORT SHOULD FURTHER ASSISTANCE BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651754 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR