BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3222950 · Received July 12, 2013

    Report

    Report Number
    2032227-2013-02856
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    December 1, 2012
    Report Date
    June 17, 2013
    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

    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

    CUSTOMER'S MOTHER CALLED TO REPORT A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. THE INSULIN PUMP HAS ALARMED NO DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE READING IS 600 MG/DL. CUSTOMER HAS TREATED WITH INSULIN PUMP AND MANUAL INJECTION. CALLER STATED THAT THE HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE HAPPENED IN (B)(6) 2012. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS OVER 600 MG/DL. DURING TROUBLESHOOTING, TIME AND DATE ARE CORRECT. PROGRAMMING IS CORRECT. THE INSULIN PUMP WILL BE REPLACED DUE TO PHYSICAL DAMAGE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323311 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization