BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4842697 · Received June 12, 2015

    Report

    Report Number
    3004209178-2015-65198
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 26, 2015
    Report Date
    May 26, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP HAD AN AIR BUBBLES IN RESERVOIR AND TUBING. CUSTOMER'S BLOOD GLUCOSE WAS 349 MG/DL. THE CUSTOMER WAS ADVISED TO CHANGE INFUSION SET. THE AIR BUBBLES DID NOT PERSIST AFTER SET CHANGE. CUSTOMER WAS ADVISED TO MONITOR AND CALL IF PROBLEMS PERSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386534 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG09UWP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR