BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4191275 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41553
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT THE CUSTOMER'S PUMP HAD NOT BEEN DELIVERING INSULIN. SPECIFICALLY, HE STATED THAT THE PUMP STOPS DELIVERING INSULIN ONCE THE RESERVOIR IS HALF WAY EMPTY. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF REPORTING. HE FURTHER STATED THAT THE RESERVOIR THREADING IS DAMAGED AND MISSING THREADING. TROUBLESHOOTING CONFIRMED THAT HE HAS RECEIVED SEVERAL LOW RESERVOIR WARNINGS AND A NO DELIVERY ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF HIS INSULIN PUMP AND REVERT TO HIS BACKUP PLAN. THE INSULIN PUMP IS BEING RETURNED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669655 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LCAS

    Patients

    Seq Age Sex Outcome Treatment
    1