BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3141135 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-94301
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE DRIVE SUPPORT DISK WAS INSPECTED AND NO DAMAGE FOUND. THE DEVICE HAD SCRATCHED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. INITIALLY, THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR SEVERAL TIMES, AND THE DRIVE SUPPORT CAP WAS FLUSH. THE CALLER ALSO MENTIONED GETTING NO DELIVERY ALARMS. THE CUSTOMER CHANGED THE INFUSION SET AND THE ISSUE WAS NOT RESOLVED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243108 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization