BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2121422 · Received June 7, 2011

    Report

    Report Number
    2032227-2011-01380
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 22, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 499 MG/DL. IT WAS ALSO REPORTED THAT THE CUSTOMER HAS A LONG HISTORY OF NON-COMPLIANCE. THE CUSTOMER HAS EXPERIENCED HIGH BLOOD GLUCOSE LEVELS FOR THE (B)(6). TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CALLER STATED THAT THE CUSTOMER'S BLOOD GLUCOSE LEVELS ARE BACK TO NORMAL NOW DUE TO AN INFUSION SET CHANGE. THE CALLER FELT NO NEED TO TROUBLESHOOT FURTHER. HOWEVER, THE CALLER DID REPORT THAT THE ESC BUTTON WAS NOT FUNCTIONING PROPERLY. TROUBLESHOOTING WAS PERFORMED, AND THE BUTTON WAS WORKING AFTER A BATTERY CHANGE. THE CUSTOMER REQUESTED A REPLACEMENT INSULIN PUMP. 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-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization