BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3180919 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-94885
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    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 REPORTED BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE OF 40MG/DL. THE CUSTOMER STATED THAT HE FEELS THE INSULIN PUMP DELIVERED INSULIN WHILE SLEEPING. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. REVIEWED THE PROGRAMMING IN THE DEVICE, AND THE BOLUS HISTORY REVEALED TWO BOLUSES OF 9.0 UNITS EACH PRIOR TO THE PARAMEDIC'S ARRIVAL. THE CUSTOMER MENTIONED THAT HE WAS INCOHERENT AT THAT TIME. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279709 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 30 YR Hospitalization