BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2031044 · Received March 16, 2011

    Report

    Report Number
    2032227-2011-00668
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS OF 820 MG/DL AFTER EXPERIENCING NAUSEA AND FLU-LIKE SYMPTOMS FOR TWO DAYS. THE CUSTOMER STATED THAT SHE CHANGED THE INFUSION SET SEVERAL TIMES PRIOR TO THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED WITH THE CORRECT TIME AND DATE. NO ALARMS OF IMPORTANCE WERE NOTED IN THE ALARM HISTORY. THE CUSTOMER WAS UNABLE TO CONTINUE TROUBLESHOOTING AT THE TIME OF THE CALL, AND STATED SHE WOULD CALL BACK IF NEEDED.

    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 72 YR Hospitalization