BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2161790 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01636
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    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

    THE CUSTOMER STATED THAT SHE WAS TREATED THREE TIMES BY THE PARAMEDICS DUE TO LOW BLOOD GLUCOSE LEVELS. THE DATES WERE (B)(6)OF 2011. THE CUSTOMER FELT THAT THE EVENTS WERE DUE TO INCORRECT BASAL RATE SETTINGS. THE CUSTOMER STATED THAT THE DAILY TOTALS DID NOT MATCH WITH THE BASAL RATE DELIVERY TOTALS. 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 MINIMED MMT-722LCAS

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention