BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4584875 · Received March 9, 2015

    Report

    Report Number
    3007981285-2015-23145
    Event Type
    Injury
    Date Received
    March 9, 2015
    Date of Event
    February 12, 2015
    Report Date
    February 12, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS (242-300 MG/DL). TROUBLESHOOTING WAS PERFORMED AND PUMP PASSED DELIVERY SYSTEM CHECK. CUSTOMER NOTICED AIR BUBBLES THROUGHOUT TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161664 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other INSULIN: NOVOLOG