BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4852808 · Received June 17, 2015

    Report

    Report Number
    3007981285-2015-35064
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 22, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP COULD NOT BE CHARGED DESPITE THE CUSTOMER ATTEMPTING MULTIPLE CABLES. THE CUSTOMER STATED THAT AN INITIAL CONNECTION CAN BE ESTABLISHED, BUT THEN THE CONNECTION GETS LOST AND THE PUMP CANNOT BE CHARGED. THE CUSTOMER BELIEVES THAT THE USB PORT IS THE ISSUE. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395879 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR