BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4843582 · Received June 12, 2015

    Report

    Report Number
    3007981285-2015-34110
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    May 16, 2015
    Report Date
    May 16, 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR EVAL. SHOULD NEW RELEVANT INFO BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOW BLOOD GLUCOSE REMINDER BECAME FROZEN ON THE PUMP SCREEN AND THE CUSTOMER WAS UNABLE TO CLEAR THE REMINDER. THE CUSTOMER STATED THAT THE LOW BLOOD GLUCOSE REMINDER HAD OCCURRED EARLIER WHEN BLOOD GLUCOSE LEVELS WERE NOT STABILIZED. HOWEVER, THE REASON FOR THE LOW BLOOD GLUCOSE LEVEL WAS NOT REPORTED. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE REMINDER WAS ABLE TO BE CLEARED. AT THE TIME OF THE CALL, THE CUSTOMER WAS NOT EXPERIENCING LOW BLOOD GLUCOSE LEVELS; HOWEVER, THE CAUSE OF THE EARLIER LOW BLOOD GLUCOSE LEVEL WAS UNABLE TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383827 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other