BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2193325 · Received July 26, 2011

    Report

    Report Number
    3004209178-2011-82275
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 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 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 HIGH BLOOD GLUCOSE AND AN INFECTION. THE BLOOD GLUCOSE READING WAS 27 MMOL/L. IT WAS STATED THAT THE CUSTOMER WAS NOT ENTERING ANY BLOOD GLUCOSE IN HER BOLUS WIZARD AND SHE WAS JUST GUESSING HER CARBOHYDRATES WHILE BEING ON A VACATION. ADVISED THAT SHE SHOULD REVERT TO BACK UP PLAN OF MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE BOLUS HISTORY REVEALED SEVERAL NO DELIVERY ALARMS. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. NO FURTHER INFORMATION 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