BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202527 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-82456
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 25, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 80MG/DL. THE CUSTOMER STATED THAT SHE FELT SICK. ADVISED THE CUSTOMER TO DISCONNECT FROM THE INSULIN PUMP AND MONITOR HER GLUCOSE LEVEL. THE CUSTOMER STATED THAT THE SECOND TIME SHE MEASURED IT WAS 45MG/DL. ASKED CUSTOMER TO TAKE GLUCOSE TABLETS AND AT THE END OF CALL WAS 103MG/DL. THE CUSTOMER STATED THAT SHE LOST CONSCIOUSNESS. THE CUSTOMER WAS EXPERIENCING LOW BLOOD GLUCOSE FOR THE PAST MONTH. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. THE CUSTOMER STATED THAT THE AMOUNT OF INSULIN IN THE SCREEN MATCH TO AMOUNT OF INSULIN IN THE RESERVOIR. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO AN MRI AND BODY SCAN AT THE AIRPORT. RAN A DISPLACEMENT TEST AND PASSED. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. 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-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization