BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION INSULIN PUMP

    MDR report key: 4110420 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-25726
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HIS INFUSION SET WAS NOT STICKING WHILE THE CUSTOMER WAS WORKING OUTSIDE. THE CUSTOMER STATED HE WAS NOT USING SOAPS OR LOTIONS ON THE INSERTION SITE. ADHESIVE SPRAY WAS WAS RECOMMENDED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592110 INFUSION INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR