BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5748145 · Received June 24, 2016

    Report

    Report Number
    3007981285-2016-88403
    Event Type
    Injury
    Date Received
    June 24, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 2, 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
    OTHER

    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 ON TWO OCCASIONS, THE CUSTOMER OBSERVED SMALL AIR BUBBLES AT THE LUER LOCK. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM 220-275 MG/DL AND A CORRECTION BOLUS WAS DELIVERED TO ADDRESS THE BG LEVEL. THE CUSTOMER PRIMED OUT THE AIR BUBBLES ON ONE OCCASION AND HAD NOT YET REMOVED THE BUBBLES AT THE TIME TANDEM TECHNICAL SUPPORT WAS CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402257 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M017303

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other