BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2800657 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-90257
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LARGE KETONES AND HIGH BLOOD GLUCOSE, AND HER BLOOD GLUCOSE WAS TREATED WITH AN INSULIN DRIP. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, AND BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED THE FATHER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. THE CALLER MENTIONED HAVING PROBLEMS WHILE HE ATTEMPTED TO REWIND AND PRIME THE INSULIN PUMP. THE FATHER STATED THAT THE INSULIN PUMP WOULD PRIME A LARGE AMOUNT OF INSULIN BEFORE DETECTING THE RESERVOIR, AND SOMETIMES THE DEVICE WOULD STOP REWINDING. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization