BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3090737 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-93076
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HOSPITALIZATION FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT TIME OF HOSPITALIZATION WAS 555 MG/DL. CUSTOMER WAS RELEASED FROM HOSPITAL ON APRIL 30, 2013. REVIEWED PROGRAMMING, NO ANOMALIES. HIGH PRESSURE TEST PASSED. CUSTOMER CHANGES INFUSION SETS EVERY SIX TO SEVEN DAYS. CUSTOMER ADVISED THAT INFUSION SETS SHOULD BE CHANGED EVERY THREE DAYS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191803 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization