BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2232582 · Received August 24, 2011

    Report

    Report Number
    3004209178-2011-82674
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 TO DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 230 MG/DL. IT WAS STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS AND THE INFUSION SET AND SITE WERE CHANGED, BUT IT DID NOT RESOLVE THE ISSUE. IT WAS STATED THAT THE CUSTOMER HAD NAUSEA AND UNEXPLAINED HIGH BLOOD GLUCOSE FOR (B)(6). THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 199 MG/DL IT WAS STATED THAT THE CUSTOMER WAS DISCONNECTED FROM THE INSULIN PUMP AND HAS BEEN TREATED WITH AN INSULIN DRIP. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE ON THE INSULIN PUMP WERE CORRECT. RAN A FIXED PRIME AND SELF TEST AND THE TESTS PASSED. THE CUSTOMER CALLED BACK AND STATED THAT HE STILL IS IN THE HOSPITAL AND HAVING THE SAME ISSUES. THE CUSTOMER REQUESTED A REPLACEMENT OF THE INSULIN PUMP. 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 CO., JUNCOS MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization