BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202363 · Received August 2, 2011

    Report

    Report Number
    2032227-2011-01911
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 629 MG/DL. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST DAY. IT WAS STATED THAT THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 215 MG/DL. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE PROGRAMMING, TIME, AND DATE WERE CORRECT, AND THE ALARM HISTORY REVEALED MOTOR ERROR AND NO DELIVERY ALARM. RAN A DISPLACEMENT AND SELF TEST AND THE INSULIN PUMP PASSED THE TESTS. PERFORMED A FIXED PRIME TEST AND THE TEST PASSED. 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-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization UNOMEDICAL INFUSION SET: MMT-975| MIO SET 32": 9MM WHITE