BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123390 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29664
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    WHILE RECEIVING ASSISTANCE WITH INSULIN PUMP SETTINGS, CUSTOMER'S DAUGHTER REPORTED THAT THE CUSTOMER WAS HOSPITALIZED APPROXIMATELY FOUR MONTHS PRIOR TO THE CALL. CUSTOMER'S DAUGHTER REPORTED THAT THE CUSTOMER WAS IN REHABILITATION AFTERWARD, AND WAS NOT WEARING THE INSULIN PUMP. CUSTOMER'S DAUGHTER REPORTED THAT THE INSULIN PUMP RETURNED AN ERROR ALARM. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602402 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization