BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090089 · Received May 5, 2011

    Report

    Report Number
    2032227-2011-01158
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. PLEASE SEE ALSO MFR REPORT NUMBER 2032227-2011-01159.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS TREATED BY THE PARAMEDICS DUE TO A BLOOD GLUCOSE READING OF 22 MG/DL. THE CUSTOMER'S LAST INFUSION SET CHANGE WAS ON THE MORNING OF THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE CUSTOMER STATED THAT HE MAY HAVE EXPOSED THE INSULIN PUMP TO AN MRI, BUT IS NOT SURE. THE CUSTOMER ALSO STATED THAT HE WEARS THE RESERVOIRS FOR MORE THAN THREE DAYS. DISCUSSED POSSIBLE CAUSES OF LOW BLOOD GLUCOSE LEVELS WITH THE CUSTOMER. 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 MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention