BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5568650 · Received April 11, 2016

    Report

    Report Number
    3007981285-2016-75636
    Event Type
    Injury
    Date Received
    April 11, 2016
    Date of Event
    March 21, 2016
    Report Date
    March 21, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THAT THE CUSTOMER RECEIVED MULTIPLE OCCLUSION ALARMS AND A CARTRIDGE ALARM 19. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 141- 560 MG/DL. THE CUSTOMER CHANGED THE INFUSION SITE AND ADMINISTERED AN INSULIN INJECTION TO ADDRESS THE HIGH BG LEVEL. TO ADDRESS THE CARTRIDGE ALARM 19, THE CUSTOMER RELOADED THE SAME CARTRIDGE AND THE ALARM WAS CLEARED. THE BG LEVEL HAD LOWERED TO 460 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222963 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other