BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3CC

    MDR report key: 2060579 · Received April 7, 2011

    Report

    Report Number
    3004209178-2011-80975
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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

    A STUDY IN (B)(6) DOCUMENTED THE EFFECTS OF AMBIENT PRESSURE ON INSULIN DELIVERY OF INSULIN PUMPS. THE FIRST PART OF THE STUDY DEMONSTRATED THAT A 300 METER ASCENT LED TO A DECREASE OF 22 MMHG IN AMBIENT PRESSURE AND FOUR INSULIN PUMPS DELIVERING 0.068 UNITS OF EXCESS INSULIN. THE SECOND PART OF THE STUDY DECREASED THE AMBIENT PRESSURE IN A HYPOBARIC CHAMBER BY 125 MMHG AND THEN 200 MMHG. THE INSULIN PUMPS DELIVERED 0.508 UNITS, THEN 0.709 UNITS OF EXCESS INSULIN. FURTHERMORE, WHEN THE HYPOBARIC CHAMBER WAS BROUGHT BACK TO SEA LEVEL PRESSURE, THE INSULIN PUMPS DELIVERED 0.533 UNITS OF INSULIN LESS THAN EXPECTED. THE THIRD STUDY WAS DONE ON AN AIRPLANE, WHERE THE AMBIENT PRESSURE WAS 560 MMHG, 200 MMHG LESS THAN SEA LEVEL. THE MEAN EXCESS INSULIN DELIVERED WAS 1.01 UNITS, OR 0.933% OF THE RESERVOIR. THE STUDY DEMONSTRATED THAT AIR BUBBLE FORMATION AND INCREASED BUBBLE SIZE WOULD OCCUR IN THE RESERVOIR, AS WELL AS RESERVOIR MOVEMENT PLUNGER MOVEMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 3CC RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1