BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2032342 · Received March 22, 2011

    Report

    Report Number
    2032227-2011-00731
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO 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 THAT THE INSULIN PUMP HAS A BLANK SCREEN, AND IS NO LONGER GIVING HER LOW RESERVOIR ALARMS. THE CUSTOMER ALSO STATED THAT SHE WAS HOSPITALIZED LAST MONTH DUE TO HIGH BLOOD GLUCOSE LEVELS. UNABLE TO TROUBLESHOOT DUE TO THE BLANK SCREEN. THE CUSTOMER WAS INTERESTED IN UPGRADING SINCE HER INSULIN PUMP WAS OUT OF WARRANTY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization