BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3141072 · Received June 3, 2013

    Report

    Report Number
    2032227-2013-02215
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 12, 2013
    Report Date
    May 12, 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

    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

    THE CUSTOMER REPORTED THAT THE PARAMEDICS WERE CALLED DUE TO HIS LOW BLOOD GLUCOSE OF 55MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED HAVING PROBLEMS FOR THE LAST TWO MONTHS BECAUSE THE READINGS ON THE INSULIN PUMP WAS DIFFERENT FROM THE BLOOD GLUCOSE METER READINGS. REVIEWED THE PROGRAMMING, AND THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. THE CUSTOMER STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. ADVISED THE CUSTOMER TO CALL BACK IF ISSUES PERSIST. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245200 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention