BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3173981 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-94797
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    August 8, 2012
    Report Date
    June 6, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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 EXPERIENCING UNEXPLAINED LOW BLOOD GLUCOSE OF 57MG/DL. REVIEWED THE PROGRAMMING, AND THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. THE CUSTOMER TREATED HER GLUCOSE LEVEL WITH ORANGE JUICE AND PEANUT BUTTER SANDWICH. THE CUSTOMER MENTIONS THAT SHE HAS WOKEN UP WITH HIGH OR LOW BLOOD GLUCOSE FOR A WEEK. THEN THE CUSTOMER CALLED BACK AND STATED THAT SHE SUSPENDED THE DEVICE AND REQUESTED ASSISTANCE WITH RESUMING ON THE INSULIN PUMP. A FOLLOW UP WAS CONDUCTED, AND FOUND THAT THE CUSTOMER WAS HOSPITALIZED IN ONE INSTANCE A YEAR AGO. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273129 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization