BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2062731 · Received April 12, 2011

    Report

    Report Number
    3004209178-2011-81017
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 31, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS TREATED BY PARAMEDICS FOR HYPOGLYCEMIA. THE CUSTOMER STATED THAT PRIOR TO THE EVENT, HE HAD BEEN FEELING SHAKY AND TAKING JUICE AND CHOCOLATE, HE STILL COULD NOT BRING HIS BLOOD GLUCOSE LEVELS UP. THE CUSTOMER THEN STATED THAT HIS BASAL RATES HAD BEEN SET TO HIGH PRIOR TO THE EVENT, AND WERE ADJUSTED BY HIS DOCTOR AFTER THE EVENT. THE CUSTOMER ALSO STATED RECEIVING SENSOR ALARMS. PROGRAMMING WAS CORRECT. 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-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention