BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3950776 · Received June 9, 2014

    Report

    Report Number
    3007981285-2014-01004
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVAL. ATTEMPTS WERE MADE TO OBTAIN ALL AVAILABLE INFO. SHOULD NEW INFO BECOME AVAILABLE, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFO STATING CARTRIDGE FILL ESTIMATE WAS 80 UNITS AFTER CUSTOMER HAD LOADED 300 UNITS OF INSULIN. THE LOAD PROCESS WAS PERFORMED AGAIN AND THE FILL ESTIMATE DISPLAYED 140 UNITS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334446 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR