BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2812741 · Received October 31, 2012

    Report

    Report Number
    3004209178-2012-90423
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 INSULIN PUMP HAS DELIVERED A BOLUS BY ITSELF TWICE. THE CALLER STATED THAT THE LAST TIME WAS THE DAY BEFORE WHILE HE WAS SLEEPING, AND THE FATHER IS NOT COMFORTABLE SINCE HE DOES NOT WAKE UP BY HIMSELF WHEN HIS BLOOD GLUCOSE IS LOW. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE READING WAS 8.8MMOL/L AND WENT TO BED. THE CUSTOMER TOOK A SMALL PORTION OF YOGURT, EQUAL TO 10 CARBOHYDRATES, AND THE INSULIN PUMP SUGGESTED TO TAKE 1.4 UNITS, WITCH IT IS CORRECT, BUT THE DEVICE GIVES HIM AUTOMATICALLY 4.0 UNITS. IT WAS STATED THAT THE CUSTOMER DID NOT PUSHED ANY BUTTONS, AND THE INSULIN PUMP HISTORY REGISTERED AS 5.5MMOL/L, 0.0 CARBOHYDRATES, AND 4.0 UNITS. THE CUSTOMER WAS TESTED AND THE INSULIN PUMP HISTORY SHOWED AS 3.0MMOL/L AND 3.0 UNITS OF ACTIVE INSULIN. THE CUSTOMER FALLS AND HE WENT INTO AN INSULIN SHOCK. IT WAS STATED THAT THE FATHER DOES NOT FEEL COMFORTABLE WITH THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWS

    Patients

    Seq Age Sex Outcome Treatment
    1