BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4781571 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-55959
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    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 THAT HE HAD AIR BUBBLES IN THE RESERVOIR. CUSTOMER'S BLOOD GLUCOSE WAS 204 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER DID NOT TREAT FOR HIS BLOOD GLUCOSE AND STATED THAT HE HAD NOT BEEN EATING WELL. CUSTOMER THEN TREATED FOR THE FOOD. CUSTOMER TAPPED THE RESERVOIR AND THE AIR BUBBLES ROSE TO THE TOP. CUSTOMER REPORTED THAT THE INSULIN WAS NOT STORED AT ROOM TEMPERATURE. CUSTOMER STATED THAT WHEN HE HAS A NO DELIVERY, HE JUST TAKES IT OFF. CUSTOMER STATED THAT IT ALWAYS ALARMS NO DELIVERY WHEN THE RESERVOIR IS EMPTY. CUSTOMER WAS ADVISED TO VERIFY THE ACCURACY OF THE PROGRAMMING WITH HIS HEALTH CARE PROFESSIONAL. CUSTOMER REPORTED THAT THE BOLUS WIZARD WAS PROGRAMMED INACCURATELY. CUSTOMER WAS ADVISED TO DO A COMPLETE SET CHANGE. CUSTOMER STATED THAT HE DOES NOT CHANGE OUT THE LANCETS VERY OFTEN AND SOMETIMES HE DOES NOT WASH HIS HANDS. CUSTOMER WILL CALL BACK WHEN IS HOME TO TROUBLESHOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325093 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326AT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR