BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2234056 · Received August 29, 2011

    Report

    Report Number
    2032227-2011-02192
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 16, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. 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 TWICE DUE TO DIABETIC KETOACIDOSIS. THE FIRST EVENT WAS ON (B)(6), 2011 WITH A BLOOD GLUCOSE READING OF 606 MG/DL. THE SECOND EVENT WAS ON (B)(6), 2011 WITH A BLOOD GLUCOSE READING OF 613 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. IT WAS STATED THAT THE CUSTOMER'S DOCTOR FELT THE INSULIN PUMP SHOULD BE REPLACED. 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-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization