BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2212849 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-82162
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN PUMP, WHICH IS NOT MARKETED IN THE U.S. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE AFTER A BOLUS. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE INSULIN PUMP DID NOT ALARM AND NO INSULIN CAME OUT OF THE TUBING. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-754WWS

    Patients

    Seq Age Sex Outcome Treatment
    1