BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2232442 · Received August 25, 2011

    Report

    Report Number
    3004209178-2011-82698
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 600MG/DL. THE CUSTOMER WAS EXPERIENCING HIGH GLUCOSE FOR THE PAST THREE MONTHS. TROUBLESHOOTING WAS PERFORMED. THE MOTHER STATED THAT WHEN THEY WENT TO THE HOSPITAL SHE NOTICED INSULIN WAS LEAKING OUT OF THE CONNECTION BETWEEN THE RESERVOIR AND THE INFUSION SET. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 76MG/DL, AND HE HAS TREATED WITH THE INSULIN PUMP. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE TESTS PASSED. IT WAS STATED THAT THE CUSTOMER CHANGES THE INFUSION SET EVERY THREE DAYS. 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 PUERTO RICO OPERATIONS MED-REL MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization PARADIGM: 6MM CATHETER| QUICK-SET: 23| UNOMEDICAL INFUSION SET: MMT-399