BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2170675 · Received July 11, 2011

    Report

    Report Number
    2032227-2011-01689
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. TROUBLESHOOTING WAS NOT POSSIBLE AT THE TIME OF THE CALL. LATER, THE CUSTOMER'S WIFE CALLED WITH MORE INFORMATION. THE CUSTOMER'S BLOOD GLUCOSE READING WAS OVER 1000 MG/DL AT THE TIME OF ADMISSION. THE WIFE ALSO STATED THAT INSULIN WAS LEAKING AT THE SITE PRIOR TO THE HOSPITALIZATION. THE WIFE DID NOT HAVE THE INSULIN PUMP WITH HER AT THE TIME OF THE CALL. THEREFORE, NO TROUBLESHOOTING WAS PERFORMED.

    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-722RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization