BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6681759 · Received June 30, 2017

    Report

    Report Number
    3007981285-2017-19082
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    June 4, 2017
    Report Date
    June 30, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED MALFUNCTION COULD NOT BE VERIFIED; HOWEVER, A DIFFERENT ISSUE WAS IDENTIFIED.

    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 HAS BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS (162-327 MG/DL). A BOLUS VIA THE PUMP WOULD BE DELIVERED TO ADDRESS THE HIGH BG. THE CUSTOMER STATED THAT FOOD CONSUMPTION AND RECENT PUMP SETTINGS WERE POSSIBLE CAUSES OF THE HIGH BG. THE CUSTOMER WAS SEEING A HEALTHCARE PROVIDER TO FINE TO THE PUMP SETTINGS. HOWEVER, THE CUSTOMER WAS ADAMANT THAT THERE WAS "SOMETHING WRONG WITH THE PUMP". THE CUSTOMER HAD INSULIN INJECTIONS AVAILABLE TO USE IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461329 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other INSULIN: NOVOLOG, INFUSION SET: T:90