BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4073267 · Received September 9, 2014

    Report

    Report Number
    2032227-2014-18349
    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 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER'S INSULIN PUMP HAD MULTIPLE BATTERY OUT LIMIT ALARMS. CUSTOMER REPLACED THE BATTERY LAST NIGHT. TODAY, WHEN SHE GOT OUT OF THE SHOWER, THE DEVICE WAS BLANK. SHE WALKED OUT OF THE BATHROOM AND THE DEVICE HAD A BATTERY OUT LIMIT ALARM. AFTER CLEANING THE BATTERY CAP AND COMPARTMENT, THE DEVICE POWERED UP RIGHT AWAY BUT ALARMED FAILED BATTERY TEST AGAIN. CUSTOMER WAS ADVISED TO TRY A FRESH BATTERY. CUSTOMER SAID SHE WOULD CALL BACK BECAUSE SHE HAD TO GO. CUSTOMER'S BLOOD GLUCOSE WAS 7.8 MMOL/L. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554779 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554CML

    Patients

    Seq Age Sex Outcome Treatment
    1