BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3122948 · Received May 21, 2013

    Report

    Report Number
    2032227-2013-02020
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 27, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    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 A MOTOR ERROR ALARM. THE CUSTOMER ALSO STATED THAT THE PARAMEDICS WERE CALLED DUE TO A LOW BLOOD GLUCOSE OF 26 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE LAST BOLUS IN THE BOLUS HISTORY WAS FOR 3.5 UNITS PRIOR TO THE EVENT. THE CUSTOMER HAD ENTERED 25 GRAMS OF CARBOHYDRATES FOR THAT BOLUS. THE INSULIN PUMP PASSED THE DISPLACEMENT AND SELF TESTS. HOWEVER, THE CUSTOMER WAS UNCOMFORTABLE USING THIS INSULIN PUMP DUE TO THE MOTOR ERROR ALARM AND THE LOW BLOOD GLUCOSE LEVELS SHE EXPERIENCED. THE CUSTOMER REQUESTED A REPLACEMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224110 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention