BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 2142384 · Received June 21, 2011

    Report

    Report Number
    2032227-2011-01538
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K972107
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 STATED THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS OVER 240 MG/DL. THE CUSTOMER HAD CHANGED THE INFUSION SET THREE TO FOUR DAYS PRIOR TO THE EVENT. THE CUSTOMER STATED THAT SHE WAS VERY DIZZY PRIOR TO BEING HOSPITALIZED. AT THE TIME OF THE CALL, THE CUSTOMER WAS UNABLE TO SEE THE SCREEN VERY WELL, BUT STATED THAT THE TIME WAS NOT CORRECT. ASSISTED THE CUSTOMER IN CORRECTING THE TIME. THE CUSTOMER STATED THAT SHE SOMETIMES WEARS THE INFUSION SETS FOR MORE THAN THREE DAYS, AND ONLY INSERTS IN HER ABDOMEN. ADVISED THE CUSTOMER TO CHANGE THE INFUSION SETS EVERY TWO TO THREE DAYS. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-507CUG

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization