BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYS

    MDR report key: 3952561 · Received May 15, 2014

    Report

    Report Number
    3007981285-2014-00631
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFO STATING THAT INSULIN WAS LEAKING FROM THE SEPTUM OF THE CARTRIDGE. THERE WAS NO IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291222 TANDEM T: SLIM INSULIN DELIVERY SYS INSULIN PUMP LZG TANDEM DIABETES 004628 M002491

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR