BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4940306 · Received July 24, 2015

    Report

    Report Number
    2032227-2015-23079
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 2, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HE WAS SITTING DOWN AND HE MAY HAVE BEEN PRESSING A BUTTON. CUSTOMER'S BLOOD GLUCOSE WAS 300 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. CUSTOMER WAS ALSO ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483783 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR