BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3160691 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-94580
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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 PARAMEDICS WERE CALLED AND HE WAS TRANSPORTED TO THE HOSPITAL DUE TO LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT HE WENT ON A LONG BIKE RIDE AND BELIEVES THERE WAS MORE INSULIN ON BOARD THAN NEEDED, AND HIS BLOOD GLUCOSE DROPPED TO 56MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE CUSTOMER WAS NOT DISCONNECTED DURING THE REWIND/PRIME PROCESS. REVIEWED THE PROGRAMMING, AND THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. THE DISPLACEMENT TEST WAS COMPLETED AND PASSED. ADVISED THE CUSTOMER TO CALL BACK IF ISSUES PERSIST. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260895 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization