BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2142335 · Received June 20, 2011

    Report

    Report Number
    2032227-2011-01510
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 5, 2011
    Manufacturer
    MEDTRONIC MINIMED
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BLANK DISPLAY AND AN ALARM DURING NORMAL USE. THE CUSTOMER ALSO STATED THAT SHE WAS IN THE EMERGENCY ROOM DUE TO BLOOD GLUCOSE LEVELS OVER 600 MG/DL. THE CUSTOMER STATED THAT SHE DIDN'T KNOW THE SCREEN WAS BLANK UNTIL SHE CHECKED HER BLOOD GLUCOSE LEVELS, AND NOTICED THAT SHE WAS OVER 600 MG/DL. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED DUE TO THE BLANK DISPLAY. 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 MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization