BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2864160 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-91209
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 24, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 UNEXPLAINED HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 300MG/DL. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE WERE INCORRECT. ASSISTED THE CALLER WITH CORRECTING. THE BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. PERFORMED A HIGH PRESSURE TEST AND PASSED. INSTRUCTED THE CALLER TO CHANGE THE ENTIRE INFUSION SET AND RESERVOIR. THE CUSTOMER DID NOT FEEL COMFORTABLE AND REQUESTED THE DEVICE 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-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization