BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2854406 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-91048
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS STUCK IN MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. HOWEVER, THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 700MG/DL. TROUBLESHOOTING WAS PERFORMED. THE FATHER STATED THAT THE HEALTH CARE PROFESSIONAL BELIEVES THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY AND REQUESTED THE DEVICE BE REPLACED. THE CALLER ALSO STATED THAT THE DEVICE ALARMED MOTOR ERROR, AND THE BATTERY WAS REMOVED FROM THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization