BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2162176 · Received July 7, 2011

    Report

    Report Number
    2032227-2011-01659
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE HIGH BLOOD GLUCOSE OF 820 MG/DL. IT WAS STATED THAT THE CUSTOMER WAS FISHING WITH THE FAMILY AND HE COLLAPSED DURING LUNCH TIME, AND THEN THE CUSTOMER WAS TAKEN TO THE HOSP. IT WAS STATED THAT THE CUSTOMER IS ON CHEMOTHERAPY DIALYSIS SIX DAYS A WEEK. IT WAS REPORTED THAT THE CUSTOMER HAD UNEXPLAINED HIGH BLOOD GLUCOSE. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 248 MG/DL AND WAS TREATED WITH THE INSULIN PUMP AND MANUAL INJECTIONS. THE PROGRAMMING, TIME AND DATE ON THE INSULIN PUMP WAS CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE INSULIN PUMP PASSED THE TEST. IT WAS STATED THAT THE ALARM HISTORY SHOWED AN ERROR ALARM. NO FURTHER INFO WAS PROVIDED.

    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 45 YR Hospitalization