BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3870928 · Received June 12, 2014

    Report

    Report Number
    3004209178-2014-85591
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 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. 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 HAD A CAR ACCIDENT THE PAST NOVEMBER AND THE CAUSE OF THE EVENT WAS THE DIFFERENCE BETWEEN THE SENSOR AND THE BLOOD GLUCOSE READINGS. APPARENTLY, SHE GOT INTO THE CAR AND HAD VERY LOW BLOOD GLUCOSE. THE CUSTOMER DID NOT MEASURE AND ASSUMED THAT THE SENSOR READING DISPLAYED ON THE INSULIN PUMP WAS CORRECT. THE CUSTOMER'S DRIVER LICENSE WAS REVOKED. THE CALLER STATED THAT SINCE THEN SHE HAS TROUBLES WITH THE SENSOR AND BLOOD GLUCOSE READINGS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347484 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWB

    Patients

    Seq Age Sex Outcome Treatment
    1