BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3852427 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-85449
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 17, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE AND WAS LETHARGIC. THE BLOOD GLUCOSE READING WAS 28.2MMOL/L AND THE CUSTOMER TREATED WITH A 15.0 UNITS OF INSULIN. IT WAS STATED THAT HE CUSTOMER CHANGED THE INFUSION SET AND THE CANNULA WAS BENT AS WELL, BUT THE INSULIN PUMP DID NOT ALARM NO DELIVERY. TROUBLESHOOTING WAS PERFORMED, AND NO DAMAGE TO THE DRIVE SUPPORT CAP NOTED. ASSISTED THE CALLER TO RUN THE MANUAL PRIME TEST AND THE INSULIN DID EXIT. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND LOW RESERVOIR ALARMS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329041 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAL

    Patients

    Seq Age Sex Outcome Treatment
    1