BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4780729 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-57427
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. THE DEVICE HAS BEEN RETURNED BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    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'S FATHER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND EXPERIENCED ISSUES WITH DELIVERY ON THE INSULIN PUMP. THE CUSTOMER HAD RECENTLY STARTED A AROUND OF STEROIDS AND AFTERWARDS WAS UNABLE TO REGULATED HIS BLOOD GLUCOSE. THE CUSTOMER HAD CHANGED THE INFUSION SET SIX OR SEVEN TIMES WITHIN A PERIOD OF FIVE DAYS. THE CUSTOMER DID NOT EXPERIENCE LEAKS, AIR BUBBLES OR BENT CANNULAS. THE CUSTOMER'S BLOOD GLUCOSE WAS REPORTEDLY OVER 600 MG/DL. THE CUSTOMER TREATED HIS HIGH BLOOD GLUCOSE WITH INSULIN PUMP THERAPY AND MANUAL INJECTIONS. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. THE CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324490 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR