BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 5729774 · Received June 16, 2016

    Report

    Report Number
    3007981285-2016-87345
    Event Type
    Injury
    Date Received
    June 16, 2016
    Date of Event
    May 24, 2016
    Report Date
    May 26, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE CALL, IT WAS REPORTED THAT THERE WAS A POSSIBILITY THAT THE CUSTOMER'S LEG MAY NEED TO BE AMPUTATED. HOWEVER, A FOLLOW UP WITH THE CONTACT WAS UNABLE TO CONFIRM IF THE LEG WAS AMPUTATED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PER TANDEM¿S T:FLEX USER GUIDE: ¿ONLY HUMALOG AND NOVOLOG HAVE BEEN TESTED BY TANDEM DIABETES CARE, INC., AND FOUND TO BE COMPATIBLE FOR USE IN THE T:FLEX SYSTEM. IT IS NOT INTENDED FOR USE WITH ANY OTHER DELIVERY SUBSTANCE.¿

    Description of Event or Problem · 1

    AT THE TIME OF THE CALL, IT WAS REPORTED THAT THERE WAS A POSSIBILITY THAT THE CUSTOMER'S LEG MAY NEED TO BE AMPUTATED. HOWEVER, A FOLLOW UP WITH THE CONTACT WAS UNABLE TO CONFIRM IF THE LEG WAS AMPUTATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2016 FOR SURGERY TO REMOVE GANGRENE FROM THE FOOT. AFTER THE PROCEDURE THE CUSTOMER WAS PLACED ON INTRAVENOUS DRIP WITH ANTIBIOTICS. THE CONTACT ALLEGED THAT THE INFECTION WAS EXACERBATED BY THE CUSTOMER'S DIABETES AND MAY/MAY NOT BE THE CAUSE OF THE GANGRENE. REPORTEDLY, THERE WERE NO ISSUES WITH THE PUMP OR SUPPLIES. IT WAS NOTED THAT THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVELS WERE STABLE AND THAT THE BG LEVEL WAS NOT A CONTRIBUTING FACTOR TO THE HOSPITALIZATION. A FOLLOW UP WITH THE CONTACT INDICATED THAT THE CUSTOMER WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2016; HOWEVER, THE CONTACT COULD NOT REMEMBER THE EXACT DATE. IT WAS NOTED THAT THE CUSTOMER WAS CURRENTLY OFF OF THE PUMP WHILE BEING TREATED FOR AN UNSPECIFIED REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384064 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 M016878

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R