BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6902158 · Received September 28, 2017

    Report

    Report Number
    3007981285-2017-28451
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    September 1, 2017
    Report Date
    September 28, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PROCODE: LZG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS HAD MULTIPLE DIABETIC KETOACIDOSIS (DKA) EVENTS. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION. TANDEM TECHNICAL SUPPORT ATTEMPTED TO CONTACT THE CUSTOMER MULTIPLE TIMES; HOWEVER, THE CUSTOMER DID NOT REPLY TO THE REQUESTS FOR INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682613 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other