BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAL

    MDR report key: 1962795 · Received January 11, 2011

    Report

    Report Number
    2032227-2011-00084
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 24, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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

    THE CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 500 MG/DL. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT AS SHE WAS CALLING FROM WORK. THE CUSTOMER DID STATE THAT SHE WEARS THE SENSOR, AND CHECKS HER BLOOD GLUCOSE LEVELS ONLY TWICE A DAY. ADVISED THAT SHE SHOULD CALIBRATE THE SENSOR THREE TO FOUR TIMES A DAY. THE CUSTOMER ALSO STATED THAT SHE REMOVED THE INSULIN PUMP, AND GAVE HERSELF MANUAL INJECTIONS, BUT HER BLOOD GLUCOSE LEVELS REMAINED ELEVATED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722LNAL PARADIGM REAL-TIME INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization