BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 4110775 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27930
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    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

    THE CUSTOMER REPORTED THAT THERE WERE AIR BUBBLES IN THE RESERVOIR NEAR THE CENTER. THE CUSTOMER DESCRIBED THE AIR BUBBLES AS BEING THE SIZE OF HER PINKY NAIL. HER BLOOD GLUCOSE WAS 146 MG/DL. THE CUSTOMER STATED SHE DID NOT REWIND THE INSULIN PUMP WITH THE RESERVOIR IN PLACE AND THE INSULIN WAS STORED AT ROOM TEMPERATURE. SHE WAS ADVISED TO PERFORM A 5 UNIT FIXED PRIME UNTIL AIR BUBBLES WERE NO LONGER VISIBLE. THE CUSTOMER WAS THEN ADVISED TO REPEAT THE FIXED PRIME AND THEN TO RESET THE FIXED PRIME BACK TO THE APPROPRIATE CANNULA PRIME AMOUNT FOR THE INFUSION SET. THE AIR BUBBLES DID NOT PERSIST AFTER A SET CHANGE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590388 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR