BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4150382 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35101
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP GAVE A BLANK DISPLAY DUE TO A BROKEN SOLDER JOINT. THE PUMP ALSO HAD MINOR SCRATCHES ON THE DISPLAY WINDOW.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD STOPPED WORKING. THE BATTERY WAS CHANGED BUT THERE WAS NO DISPLAY ON THE INSULIN PUMP AND THERE HAD NOT BEEN A DISPLAY FOR SEVERAL HOURS. THE CUSTOMER STATED THAT THEY WANTED TO DELIVER A BOLUS AND HAD NOTICED THAT THE DISPLAY OF THE DEVICE WAS BLANK AND THE DEVICE HAD TURNED OFF. THE CUSTOMER'S BLOOD GLUCOSE WAS 6.4 MMOL/L. THERE WERE NO SIGNS OF PHYSICAL DAMAGE ON THE DEVICE. THE DEVICE HAD NOT BEEN DROPPED OR BUMPED. THE DEVICE WAS NOT EXPOSED TO MOISTURE. THE BATTERY CAP, THE SPRING AND THE BATTERY COMPARTMENT WERE NOT DAMAGED OR CORRODED. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ASKED TO CLEAN THE BATTERY CAP AND THE CONTACTS AND TO INSERT A NEW BATTERY, BUT THE DISPLAY DID NOT RETURN, STILL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629305 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LWWS

    Patients

    Seq Age Sex Outcome Treatment
    1