BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2032306 · Received March 22, 2011

    Report

    Report Number
    3004209178-2011-80755
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 559 MG/DL. THE CUSTOMER STATED THAT PRIOR TO THE EVENT, THE CUSTOMER HAD CHANGED OUT THE INSULIN PUMP AND WAS FEELING SICK. THE CUSTOMER THEN STATED THAT SHE HAD TO LEAVE AND DID NOT HAVE TIME TO CHANGE OUT THE INFUSION SET. THE CUSTOMER ALSO STATED THAT WHEN THE PARAMEDICS CAME, THEY REMOVED THE INFUSION SET AND FOUND A BENT CANNULA. THE CUSTOMER WAS USING AN MMT-399 PARADIGM QUICK-SET INSULIN INFUSION SET. PROGRAMMING WAS CORRECT AND TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    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-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization (B)(4) PARADIGM QUICK-SET INSULIN INFUSION SET