BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090183 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-81390
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 341MG/DL. THE CUSTOMER STATED THAT LATER HER GLUCOSE ROSE TO 416MG/DL. THE CUSTOMER STATED HAVING HIGH GLUCOSE FOR THE PAST TWENTY FOUR HRS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE CANNULAS WERE BENT. THE PROGRAMMING AND SETTINGS ON THE INSULIN PUMP WERE 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-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization