BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 5097584 · Received September 23, 2015

    Report

    Report Number
    2032227-2015-42921
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 27, 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 "PHARMACOKINETICS AND TOLERABILITY OF EXENATIDE DELIVERED BY 7-DAY CONTINUOUS SUBCUTANEOUS INFUSION IN HEALTHY VOLUNTEERS" BY VLASAKAKIS G., JOHNSON S.L., LIN J., YAO X., GRUENLOH C.J., CHISM J.P., NUNEZ D.J. FROM ADV. THER. 2015 32:7 (650-661) FOCUSED ON FORMULATIONS OF SMALL PEPTIDES TO TREAT TYPE 2 DIABETES MELLITUS DELIVERED BY CONTINUOUS SUBCUTANEOUS INFUSION. SYSTEMATIC EXPOSURE OF EXENATIDE, AN EXEMPLAR PEPTIDE, WAS INFUSED IN HEALTHY SUBJECTS USING PARADIGM REVEL INSULIN INFUSION PUMPS. THREE ADVERSE EVENTS WERE NOTED IN THE STUDY, BUT NONE WERE CONSIDERED SERIOUS OR LED TO WITHDRAWAL FROM THE STUDY. IT WAS ALSO FOUND INFUSION OF EXENATIDE WAS INTERRUPTED FOR SEVERAL HOURS DURING THE NIGHT OF DAY 6 OF THE STUDY DUE TO AN INFUSION SET DETACHMENT. THE STUDY SHOWED SUSTAINED DELIVERY USING AN INFUSION PUMP ALLOWED CONTROL AND FLEXIBILITY WHEN INVESTIGATING PHARMACOKINETIC/PHARMACODYNAMICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628716 INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1