BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2823276 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-90613
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO KETOACIDOSIS. IT WAS STATED THAT THE CUSTOMER WAS NOT USING THE INSULIN PUMP AT TIME OR PRIOR TO THE ADMISSION. THE INSULIN PUMP ALARMED NO DELIVERY AND THE CUSTOMER WAS DISCONNECTED FROM THE DEVICE SEVERAL DAYS BEFORE THE EVENT. IT WAS STATED THAT THE CUSTOMER WAS NOT COMFORTABLE WITH THE INSULIN PUMP AND REQUESTED THE DEVICE BE REPLACED. 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-522WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization