BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3191780 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-95063
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    January 28, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 170MG/DL. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD WERE CORRECT. THE CUSTOMER MENTIONED THAT HE SWITCHED OVER TO THE NEW INSULIN PUMP AND HIS BLOOD GLUCOSE WAS UNCONTROLLABLE. THE CUSTOMER DID BELIEVE THAT SOMETHING WAS WRONG WITH THE DEVICE. A PHONE CALL WAS MADE TO THE CUSTOMER TO FOLLOW UP ON A PREVIOUS CALL THE CUSTOMER MADE AND STATED THAT HE WAS HOSPITALIZED TWICE WITHIN THE LAST COUPLE OF MONTHS, AND HE IS NOT SURE THE DATES OR IF IT WAS BECAUSE THE ORIGINAL INSULIN PUMP WAS MALFUNCTIONING. THE CALLER STATED THAT HE RECEIVED A REPLACEMENT AND HE IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290979 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization