BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2800572 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-90231
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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 HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 398/280 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT. REVIEWED THE ALARM HISTORY AND FOUND MULTIPLE ERROR ALARMS AND NO DELIVERY ALARMS. THE CUSTOMER'S BLOOD GLUCOSE WAS TREATED WITH MANUAL INJECTIONS. THE MOTHER MENTIONED THAT THE INSULIN, SITES, AND SUPPLIES HAVE BEEN CHANGED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization