BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4122579 · Received September 18, 2014

    Report

    Report Number
    2032227-2014-24647
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    July 19, 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
    CA, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ABOUT A MONTH EARLIER, THE INSULIN PUMP'S ACT BUTTON BECAME INCREASINGLY UNRESPONSIVE. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THIS PROBLEM. 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
    579018 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR