BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3160713 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-94585
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 453MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED THE FATHER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. REVIEWED THE ALARM HISTORY AND FOUND NO DELIVERY AND LOW RESERVOIR ALARMS. ADVISED THE FATHER TO CALL BACK WHEN THE TUBING CLAMP ARRIVES TO CONTINUE TESTING. INSTRUCTED THE CALLER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. THE FATHER CALLED BACK AND REQUESTED A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260427 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization