BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6349554 · Received February 22, 2017

    Report

    Report Number
    3007981285-2017-04892
    Event Type
    Injury
    Date Received
    February 22, 2017
    Date of Event
    February 24, 2016
    Report Date
    February 22, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD EXPERIENCED ONGOING, INTERMITTENT HIGH BLOOD GLUCOSE (BG) LEVELS (200-456 MG/DL). A BOLUS VIA THE PUMP WAS DELIVERED TO ADDRESS THE HIGH BG. THE CUSTOMER STATED THAT THE HIGH BG WAS DUE TO HER OWN BODY'S NATURAL BG FLUCTUATIONS AND THOUGHT THAT OCCASIONALLY, THE INFUSION SET SITES DID NOT ABSORB INSULIN VERY WELL. HOWEVER, THE INFUSION SET SITES DID NOT HAVE ANY NOTED ISSUES DURING THESE PAST EVENTS. AFTER CHANGING THE CURRENT INFUSION SET SITE, THE CUSTOMER'S BG HAD DECREASED. NO DAMAGE WAS OBSERVED TO THE CANNULA AND THE CUSTOMER THOUGHT THIS WAS AN ABSORPTION ISSUE. THE CUSTOMER DECLINED TANDEM TECHNICAL SUPPORT'S OFFER TO TROUBLESHOOT AS THE CUSTOMER STATED THE PUMP AND SUPPLIES WERE FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131394 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other INFUSION SET: INSET, INSULIN: HUMALOG