BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2234052 · Received August 29, 2011

    Report

    Report Number
    2032227-2011-02188
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 13, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS. CALLED THE CUSTOMER FOR MORE INFORMATION AS SHE WAS NOT PRESENT DURING THE INITIAL CALL. THE CUSTOMER STATED THAT SHE WAS ADMITTED WITH BLOOD GLUCOSE LEVELS OVER 500 MG/DL. THE CUSTOMER HAD CHANGED THE INFUSION SET THE NIGHT PRIOR TO THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE CUSTOMER WAS UNABLE TO CONTINUE WITH THE TROUBLESHOOTING AT THIS TIME. ADVISED THE CUSTOMER TO CALL BACK AT HER CONVENIENCE TO FINISH THE TROUBLESHOOTING. 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-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization