BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6196650 · Received December 21, 2016

    Report

    Report Number
    3007981285-2016-27176
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    December 13, 2016
    Report Date
    December 13, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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'S BLOOD GLUCOSE (BG) HAD BEEN RANGING FROM 150-223 MG/DL. THE CUSTOMER THOUGHT THAT BG LEVEL WAS DUE TO THE DINNER/DESSERT THAT WAS CONSUMED AND A CORRECTION BOLUS WAS DELIVERED VIA THE PUMP TO ADDRESS THE BG. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, AN AIR BUBBLE WAS OBSERVED IN THE LUER LOCK. THE CUSTOMER WAS TO CHANGE OUT THE CARTRIDGE AND INFUSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843208 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR INFUSION SET: CLEO, INSULIN: NOVOLOG