BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4073266 · Received September 9, 2014

    Report

    Report Number
    2032227-2014-18348
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.(B)(4).

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE. INSULIN PUMP HAD NO BLANK DISPLAY NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER'S INSULIN PUMP SHUT OFF YESTERDAY. CUSTOMER PLAYED WITH THE BATTERY CAP AND THE DEVICE TURNED BACK ON. THE SAME ISSUE OCCURRED TODAY. THE BATTERY COMPARTMENT IS CRACKED. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554066 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554CMS

    Patients

    Seq Age Sex Outcome Treatment
    1