BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6045263 · Received October 20, 2016

    Report

    Report Number
    3007981285-2016-15183
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 30, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 MULTIPLE, INTERMITTENT OCCLUSION ALARMS. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 495 MG/DL AND AN INSULIN INJECTION WAS USED TO ADDRESS THE BG LEVEL. THE CAUSE OF THE PAST OCCLUSIONS COULD NOT BE DETERMINED AND AS THE CUSTOMER HAD CHANGED THE SUPPLIES AFTER THE MOST RECENT OCCLUSION, A SYSTEM CHECK WAS UNABLE TO BE PERFORMED TO DETERMINE A POSSIBLE CAUSE OF THE OCCLUSION. THE CUSTOMER REPORTED TO HAVE USED THE ABDOMEN FOR THE INFUSION SET SITE FOR THE PAST 10 YEARS AND INDICATED THAT ANOTHER AREA WOULD BE USED DURING THE NEXT SITE CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696449 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other INFUSION SET: INSET, INSULIN: HUMALOG