BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090043 · Received May 4, 2011

    Report

    Report Number
    3004209178-2011-81329
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    April 2, 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 Location
    CA
    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. 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 FOR HIGH BLOOD GLUCOSE OF 360MG/DL. IT WAS STATED THAT AFTER THE INFUSION SET WAS CHANGED, THE CUSTOMER'S BLOOD GLUCOSE STARTED TO RISE. IT WAS ALSO STATED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE FOR THE PAST THREE DAYS. IT WAS STATED THAT THE CUSTOMER'S MOST RECENT BLOOD GLUCOSE WAS 396MG/DL AND CUSTOMER TREATED WITH THE INSULIN PUMP AND MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. RAN A FIXED PRIME TEST AND THE INSULIN PUMP 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-722CAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization