BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090028 · Received May 4, 2011

    Report

    Report Number
    3004209178-2011-81345
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    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 UNKNOWN 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 FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 178MG/DL. IT WAS STATED THAT THE CUSTOMER WAS VOMITING, NAUSEA, AND ABDOMINAL PAIN. IT WAS STATED THAT THE CUSTOMER WAS NOT ABLE TO CONTROL HER GLUCOSE LEVEL. IT WAS STATED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE FOR THE PAST THREE DAYS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 79MG/DL AND CUSTOMER TREATED WITH THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER HAS CHANGED THE INFUSION SET TO RESOLVE THE ISSUE. REVIEWED THE PROGRAMMING ON THE INSULIN PUMP. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. PERFORMED A HIGH PRESSURE TEST AND THE INSULIN PASSED THE TEST. 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-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization