BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202364 · Received August 2, 2011

    Report

    Report Number
    2032227-2011-01912
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 13, 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
    NJ, 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 DUE TO KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 700 MG/DL. THE CUSTOMER STATED THAT THE LAST INFUSION SET CHANGE PRIOR TO HER ADMISSION WAS ON (B)(6) 2011. THE CUSTOMER STATED THAT HER GLUCOSE LEVEL DID NOT LOWER AFTER BOLUSING. THE CUSTOMER WAS FEELING NAUSEA THE DAY BEFORE THE EVENT. THE CUSTOMER STATED THAT SHE WAS GOING TO SCHOOL AND ENDED UP GOING TO THE HOSP. THE CUSTOMER WAS EXPERIENCING UNEXPLAINED HIGH GLUCOSE FOR THE PAST WEEK. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 186 MG/DL, AND SHE HAS TREATED WITH THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. RAN A FIXED PRIME TEST AND HIGH PRESSURE TEST AND PASSED. THE CUSTOMER MENTIONED HAVING A MOTOR ERROR DURING BASAL. PERFORMED A DISPLACEMENT AND SELF TEST AND THE TESTS 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 26 YR Hospitalization QUICK-SET: 23| PARADIGM: 9MM CATHETER| UNOMEDICAL INFUSION SET: MMT-397