BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3813026 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-84622
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY
    Reporter Occupation
    PATIENT

    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

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED IN THE EARLY HOURS TO LET HER KNOW THAT SHE NEEDS TO BOLUS AND HER GLUCOSE LEVEL WAS 240MG/DL. THE CALLER ATTEMPTED TO MOVE OFF THE 25 UNITS, BUT IT DID NOT MOVE AND STILL GAVE HIM 25 UNITS OF INSULIN. THE NEXT MORNING THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE AND THE PARAMEDICS WERE CALLED. THE CUSTOMER STATED THAT HIS WIFE FOUND HIM AFTER HE HAD A SANDWICH AND JUICE. THE CUSTOMER WAS CONVULSING ON THE FLOOR AND THEN WOKE UP. TROUBLESHOOTING WAS PERFORMED, AND NO DAMAGE TO THE DRIVE SUPPORT CAP NOTED. REVIEWED THE PROGRAMMING, AND THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. ASSISTED THE CUSTOMER TO RUN THE DISPLACEMENT TEST AND PASSED. THE CALLER STATED THAT SHE DOES NOT KNOW HOW 24.0 UNITS OF INSULIN WERE DELIVERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290785 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR