BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6078931 · Received November 4, 2016

    Report

    Report Number
    3007981285-2016-17043
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 BY THE CONTACT THAT THE CUSTOMER HAD BEEN HOSPITALIZED FOR DIABETIC KETOACIDOSIS. THE CONTACT WAS CONCERNED THAT THE PUMP WAS NOT WORKING PROPERLY AS THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT RESPONDING TO THE BOLUSES THAT WERE DELIVERED VIA THE PUMP. THE CONTACT DID NOT HAVE ANY ADDITIONAL INFORMATION. ALTHOUGH MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729841 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R