BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3182772 · Received June 21, 2013

    Report

    Report Number
    2032227-2013-02526
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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

    CUSTOMER CALLED TO REPORT A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. THE CURRENT BLOOD GLUCOSE READING IS 364 MG/DL. CUSTOMER CALLED FROM HOSPITAL. CUSTOMER EXPERIENCED THIRST AND LETHARGY. CUSTOMER WOKE UP WITH A BLOOD GLUCOSE READING OF 397 MG/DL. THE HIGHEST READING WAS ALMOST 600 MG/DL. DURING TROUBLESHOOTING, TIME AND DATE ARE CORRECT. PROGRAMMING IS CORRECT. MANUAL PRIME IS CORRECT, INSULIN EXITS THE TUBING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283441 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization