BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4031729 · Received August 22, 2014

    Report

    Report Number
    3004209178-2014-97180
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD ALARMED SEVERAL TIMES MOTOR ERROR AND CUSTOMER HAD ALSO OCCLUSIONS. IT WAS STATED THAT THE CUSTOMER HAD REPORTED PREVIOUS EVENTS REGARDING THIS ISSUE. CUSTOMER STATED THAT THE LAST MOTOR ERROR ALARM WAS IN (B)(6). THE MOTOR ERROR ALARM OCCURRED TWICE DURING AN INSULIN BOLUS DELIVERY, ONE TIME SPONTANEOUSLY AND ONE TIME AFTER AN OCCLUSION. IT WAS STATED THAT FOR ALL TIMES THE CUSTOMER WAS ABLE TO REWIND AND USE THE INSULIN PUMP AGAIN. THE DEVICE WAS BUMPED. IT WAS ALSO IN A SCAN, BUT THIS WAS AFTER THE MOTOR ERROR ALARM. CUSTOMER DOES NOT USE THE SENSOR FEATURE. BLOOD GLUCOSE VALUE IS 4.1 MMOL/L. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508967 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWH

    Patients

    Seq Age Sex Outcome Treatment
    1