BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4090413 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23108
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A NO DELIVERY ALARM ON HER INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 364 MG/DL. SHE TREATED WITH A BOLUS. IN A FIXED PRIME, INSULIN EXITED THE TUBING AND THE DEVICE ALARMED NO DELIVERY. CUSTOMER DISCONNECTED AND RECONNECTED THE RESERVOIR AND INFUSION SET AT THE TUBING CONNECTOR AND SHE PUSHED INSULIN THROUGH. SHE THEN REINSERTED THE RESERVOIR AND RAN A MANUAL PRIME AND INSULIN EXITED. CUSTOMER WAS ADVISED THE ALARM WAS CAUSED BY AN INFUSION SET OR RESERVOIR OCCLUSION. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568284 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A H8173079

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR