BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2943417 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-90628
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 ADMITTED IN THE INTENSIVE CARE UNIT DUE TO HIGH BLOOD GLUCOSE OF 551 MG/DL, AND HER BLOOD GLUCOSE WAS TREATED WITH AN INSULIN DRIP. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED A HIGH PRESSURE TEST AND THE TEST FAILED TWICE. ADVISED THE HUSBAND THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. THE CALLER MENTIONED THAT THE CUSTOMER IS NOT STANDING DURING INSERTION. INSTRUCTED THE HUSBAND TO REMOVE THE CANNULA AND IT WAS NOT BENT. RECOMMENDED THE CALLER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR EVERY TWO TO THREE DAYS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40651 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization