BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3133503 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-94111
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    IT WAS REPORTED THAT THE CUSTOMER IS HAVING HIGH BLOOD GLUCOSE WHILE BEING AT THE SCHOOL, AND THE NURSE WAS WATCHING HER BLOOD GLUCOSE. LATER THE MOTHER CALLED BACK AND STATED THAT THE CANNULA WAS BENT, BUT THE INSULIN PUMP DID NOT ALARM NO DELIVERY. IT WAS STATED THAT THE CUSTOMER ATE 2 DONUTS AROUND 6:49PM AND BOLUSED 2.6 UNITS TO COVER 68 CARBOHYDRATES. AROUND 9:00PM HER BLOOD GLUCOSE WAS OVER 130MG/DL, AND IN THE MORNING IT WAS 204MG/DL, WHICH THE MOTHER SAYS IS ABNORMAL WHEN THE CUSTOMER IS ON LANTUS. HOURS LATER HER GLUCOSE LEVEL WENT UP TO 419MG/DL. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD WERE CORRECT. THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. ASSISTED THE CALLER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. PERFORMED THE HIGH PRESSURE TEST AND PASSED. ADVISED THE MOTHER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234653 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR