BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2103783 · Received May 18, 2011

    Report

    Report Number
    3004209178-2011-81495
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 8, 2011
    Report Date
    May 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    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 CALLED TO REPORT THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS, WITH A READING OF 35 MG/DL. PRIOR TO THE HOSPITALIZATION, THE CUSTOMER GAVE HERSELF A BOLUS OF 5.0 UNITS AFTER READING ON HER SENSOR THAT THE READING WAS 400 MG/DL. ADVISED THE CUSTOMER NEVER TO TREAT OFF OF THE SENSOR READING, AND TO ALWAYS CONFIRM WITH A FINGERSTICK READING. THE CUSTOMER'S LAST INFUSION SET CHANGE WAS ON (B)(6) 2011. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE RESERVOIR VOLUME WAS ALSO CORRECT. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization