BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6002967 · Received October 6, 2016

    Report

    Report Number
    3007981285-2016-13790
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 13, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S TANDEM CLINICAL DIABETES SALES SPECIALIST REPORTED THAT THE CUSTOMER HAS CHANGED TO CONTACT DETACH INFUSION SETS AND BELIEVE THAT THEY ARE A BETTER OPTION. 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 CUSTOMER WOKE UP WITH AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 400 (MG/DL). CUSTOMER CHANGED THEIR INFUSION SITE AND ADMINISTERED INSULIN INJECTIONS TO TREAT THEIR BG LEVEL. SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT INDICATED PUMP WAS PERFORMING AS INTENDED. REPORTEDLY, CUSTOMER USES HUMALOG INSULIN IN THE PUMP CARTRIDGES FOR 2-3 DAYS AT A TIME; HOWEVER, THE CARTRIDGE ON THE PUMP DURING THE ELEVATED BG LEVEL WAS ONLY IN USE FOR 1 DAY. CUSTOMER WAS REMINDED THAT HUMALOG IS INDICATED FOR USE UP TO 48 HOURS, AND RECOMMENDATION WAS MADE TO CONSULT WITH THEIR HEALTH CARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656243 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other INFUSION SET: T:90, INSULIN: HUMALOG