BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933298 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-87045
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER CALLED IN STATING THAT CUSTOMER AND FAMILY ARE ON VACATION RIGHT NOW AND HAVING ISSUES WITH HIGH BLOOD GLUCOSE LEVELS. CUSTOMER WENT SWIMMING AND TOOK OFF THE DEVICE FOR ABOUT TWO HOURS. AFTER RECONNECTING TO THE DEVICE, CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 303 MG/DL. SHE CORRECTED WITH THE INSULIN PUMP. A FEW HOURS LATER, CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 594 MG/DL, AND CUSTOMER TREATED WITH AN INJECTION. CUSTOMER WAS FEELING THIRSTY AND HAVING STOMACH PAINS. THE DRIVE SUPPORT CAP APPEARS NORMAL. INSULIN EXITED THE TUBING DURING MANUAL PRIME. THERE IS NO LEAK. TROUBLE SHOOTING COULD NOT BE COMPLETED BECAUSE CUSTOMER DOES NOT HAVE A TUBING CLAMP. WHEN CUSTOMER CHANGED HER INFUSION SET, THE CANNULA WAS BENT. IT WAS EXPLAINED THAT HIGH BLOOD GLUCOSE LEVELS ARE OFTEN CAUSED BY INFUSION SET OR SITE ISSUES. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409385 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