BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 4721164 · Received April 22, 2015

    Report

    Report Number
    2032227-2015-13467
    Event Type
    Malfunction
    Date Received
    April 22, 2015
    Date of Event
    September 26, 2013
    Report Date
    January 28, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT DUE TO THE LIMITED SCOPE OF THE STUDY. 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 ON "INSULIN PUMP FAILURES: A PROSPECTIVE STUDY" BY ESVANT A., GUILHEM I., BREITEL S., CUGGIA M., LEGUERRIER A.-M., POIRIER J.-Y. FROM DIABETOLOGIA 2014 57:1 SUPPL. 1 (S415-S416) FOCUSED ON 314 NEW INSULIN PUMPS BETWEEN 2008 AND 2011. MALFUNCTIONS DIRECTLY RELATED TO MEDTRONIC'S PARADIGM 522/722 INSULIN PUMPS WERE ONE OF THE FOCUSES OF THE STUDY. THE STUDY REVEALED 11% OF INSULIN PUMPS MALFUNCTIONED FROM COMPLETE FAILURES, 7% MALFUNCTIONED FROM ALARMS AND 36% MALFUNCTIONED FROM MECHANICAL FAILURES. COMPLETE FAILURES OF THE INSULIN PUMPS WERE DETERMINED TO BE CAUSED BY INOPERATIVE KEYPAD AND MECHANICAL DEFECTS WERE CAUSED BY CRACKS IN THE RESERVOIR OR BATTERY COMPARTMENT. THE STUDY ALSO FOUND THE SURVIVAL TIME OF PARADIGM 522/722 INSULIN PUMPS WAS SHORTER THAN PARADIGM VEO INSULIN PUMPS. HOWEVER, THE STUDY ALSO SHOWED THE PROPORTION OF SEVERE INSULIN PUMP FAILURES WERE HIGHER IN PARADIGM VEO INSULIN PUMPS COMPARED TO OTHER INSULIN PUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265469 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1