BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6141439 · Received December 2, 2016

    Report

    Report Number
    3007981285-2016-22377
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 12, 2016
    Report Date
    November 12, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    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 THAT THE CUSTOMER RECEIVED A MINIMUM FILL MESSAGE WHEN ATTEMPTING TO LOAD A CARTRIDGE. REPORTEDLY, THE CARTRIDGE WAS FILLED WITH APPROXIMATELY 150 UNITS OF INSULIN. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL DUE TO NOT TESTING. AS THE CUSTOMER DID NOT HAVE ADDITIONAL INSULIN AVAILABLE DURING THE TIME OF THE CALL, A NEW CARTRIDGE WAS NOT LOADED ONTO THE PUMP. THE CUSTOMER DECLINED FURTHER FOLLOW-UP FROM TANDEM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792550 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR