BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3182737 · Received June 21, 2013

    Report

    Report Number
    2032227-2013-02510
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 29, 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

    CUSTOMER STATED THAT A HOSPITALIZATION WAS DUE TO HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT INSULIN PUMP ALARMED NO DELIVERY MULTIPLE TIMES. CUSTOMER EXPERIENCED NAUSEA AND FEELING TIRED. CUSTOMER BLOOD GLUCOSE READING AT THE TIME OF THE INCIDENT WAS 474 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283132 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization