BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4002453 · Received June 10, 2014

    Report

    Report Number
    3007981285-2014-01095
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 11, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RECEIVED INFO STATING CUSTOMER RECEIVED AN OCCLUSION ALARM. THERE WAS NO REPORTED IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER WOULD PRESS "RESUME" ON THE PUMP INSTEAD OF CHANGING THE CARTRIDGE, TUBING AND CANNULA AFTER THE ALARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337240 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M002957

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR INSULIN: HUMALOG| INFUSION SET: INSET