BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2063124 · Received April 12, 2011

    Report

    Report Number
    3004209178-2011-81009
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE A DELIVERY ANOMALY WITH THE INSULIN PUMP. THE CUSTOMER'S MOTHER STATED THAT FOR THE THREE DAYS PRIOR TO THIS REPORT, THE CUSTOMER HAD BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS, WITH SYMPTOMS SUCH AS CONFUSION AND THE INABILITY TO FOLLOW SIMPLE COMMANDS. THE CUSTOMER'S MOTHER ALSO STATED THAT THE CUSTOMER'S DOCTOR HAD CORRECTED THE BASAL RATES ON THE INSULIN PUMP A MONTH BEFORE THE REPORT. NOTHING FURTHER WAS REPORTED.

    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-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR