BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2232596 · Received August 24, 2011

    Report

    Report Number
    3004209178-2011-82669
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN A CAR ACCIDENT AND HIS GLUCOSE LEVEL IS SHOWING 3MG/DL. IT WAS STATED THAT THE MOTHER DID NOT HAVE THE INSULIN PUMP TO TROUBLESHOOT AT TIME OF CALL. THE MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO THE ACCIDENT. IT WAS STATED THAT THE MOTHER BELIEVES THE INSULIN PUMP IS NOT FUNCTIONING PROPERLY AND REQUESTED A REPLACEMENT OF THE INSULIN PUMP. ADVISED THE MOTHER THAT THE CUSTOMER SHOULD REVERT TO BACK UP PLAN UNTIL THE REPLACEMENT OF THE INSULIN PUMP ARRIVES. 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 MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization