BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2210099 · Received August 3, 2011

    Report

    Report Number
    2032227-2011-01925
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. 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 HIGH BLOOD GLUCOSE READING OF 706 MG/DL. THE CUSTOMER HAD BEEN VOMITING PRIOR TO BEING ADMITTED. THE CUSTOMER WAS THEN TRANSFERRED TO ANOTHER HOSPITAL WITH A BLOOD GLUCOSE READING OF 600 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. A BUTTON ERROR WAS FOUND IN THE ALARM HISTORY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED DUE TO THE BUTTON ERROR ALARM. 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-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization