BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3895420 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03132
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 22, 2014
    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. 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.

    Additional Manufacturer Narrative · 1

    THE BLOOD GLUCOSE METER COMMUNICATED PROPERLY AND ALL DATA MATCHED PROPERLY WITH THE INSULIN PUMP. THE INSULIN PUMP FUNCTIONED PROPERLY DURING THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM, AND DISPLACEMENT TESTS. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HIGH BGS OF 20 MMOL/L. THE PATIENT HAD TREATED WITH THE PUMP BUT CONTINUED EXPERIENCING HIGH BG. TROUBLESHOOTING WAS PERFORMED, AND IT WAS STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369994 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-754LCML

    Patients

    Seq Age Sex Outcome Treatment
    1