BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4122581 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24648
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK 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

    CUSTOMER REPORTED THAT THE INSULIN PUMP'S BUTTONS WERE NO LONGER RESPONDING. CUSTOMER REPORTED THAT THIS ISSUE BEGAN IN THE WEEK PRIOR TO THE CALL AND HAS GOTTEN INCREASINGLY WORSE. CUSTOMER SATED THAT THE B BUTTON WAS NOT RESPONDING AT ALL. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THIS ISSUE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS NOT PROVIDED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579289 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR