BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6332422 · Received February 15, 2017

    Report

    Report Number
    3007981285-2017-05508
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    January 28, 2017
    Report Date
    February 15, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2017: DURING FOLLOW UP WITH TANDEM TECHNICAL SERVICES THE CUSTOMER REPORTED THAT THEIR BLOOD GLUCOSE LEVEL RETURNED TO TARGET RANGE. THE T:SLIM CARTRIDGE USER GUIDE INDICATES THAT HUMALOG HAS BEEN TESTED UP TO 48 HOURS. REPLACE THE CARTRIDGE EVERY 48 HOURS IF USING HUMALOG. 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 EXPERIENCED A HIGH BLOOD GLUCOSE (BG) LEVEL OF 250-370 MG/DL. THE CUSTOMER DELIVERED A BOLUS AND CHANGED OUT THE INFUSION SITE TO ADDRESS BG LEVEL. THE CUSTOMER REPORTED THAT THE CAUSE OF THE HIGH BG WAS UNKNOWN. REPORTEDLY, THE CUSTOMER HAD CHANGED OUT THE CARTRIDGE EVERY 5-6 DAYS. TROUBLESHOOTING WITH TANDEM CUSTOMER TECHNICAL SERVICES (CTS) DETERMINED THE PUMP FUNCTIONED AS INTENDED. CTS RECOMMENDED TO THE CUSTOMER TO CONTACT THEIR HEALTHCARE PROVIDER REGARDING CAUSES OF HIGH BG FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116979 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M017273

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other INFUSION SET: CONTACT DETACHINSULIN: HUMALOG