BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5322750 · Received December 23, 2015

    Report

    Report Number
    3007981285-2015-63324
    Event Type
    Injury
    Date Received
    December 23, 2015
    Date of Event
    November 25, 2015
    Report Date
    December 1, 2015
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (BRAND NAME- ADDED "TANDEM T:SLIM INSULIN DELIVERY SYSTEM"). (COMMON DEVICE NAME- CORRECTED TO "INSULIN PUMP"). (PROCODE- CORRECTED TO "LZG"). (MODEL #- ADDED "004628", CATALOG #- ADDED "004629", SERIAL #- ADDED " (B)(4)"). PMA/510K #- ADDED "K111210". DEVICE MANUFACTURE DATE- ADDED "9/20/2012".

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVEL REMAINED ELEVATED (367 MG/DL) WITH MILD KETONES. CUSTOMER DELIVERED MULTIPLE BOLUSES AND MANUAL INJECTIONS. HEALTH CARE PROVIDER PROVIDED LANTUS FOR USE WITH NOVOLOG PENS. CUSTOMER INCREASED PUMP BASAL SETTINGS AND CHANGED OUT INFUSION SITE TWICE. SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND NO ISSUES WERE NOTED. CUSTOMER WAS NOT CURRENTLY USING THE PUMP AND MORE SUPPLIES WERE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847070 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M015545

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention