BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6184278 · Received December 17, 2016

    Report

    Report Number
    3007981285-2016-25965
    Event Type
    Injury
    Date Received
    December 17, 2016
    Date of Event
    October 19, 2016
    Report Date
    December 4, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM PUMP USER GUIDE INDICATES THAT THE CARTRIDGE IS CONTRAINDICATED FOR USE WITH PRODUCTS OTHER THAN HUMALOG AND NOVOLOG. 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, INTERMITTENT OCCLUSION ALARMS. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 240-350 MG/DL AND INSULIN INJECTIONS WERE ADMINISTERED TO ADDRESS THE BG LEVEL. THE CUSTOMER HAD REVERTED TO USING INSULIN INJECTIONS TO MANAGE DIABETES. REPORTEDLY, THE CUSTOMER'S HEALTHCARE PROVIDER HAD PRESCRIBED APIDRA INSULIN AFTER THE CUSTOMER HAD RUN OUT OF THE HUMALOG INSULIN. THE OCCLUSIONS APPEARED TO BEGUN WHEN THE APIDRA WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834723 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other INSULIN: APIDRA, INFUSION SET: INSET, COMFORT SHOR