BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-712LNAS PRDGM INS SK EN US LN

    MDR report key: 1060344 · Received June 13, 2008

    Report

    Report Number
    2032227-2008-00982
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED SHE WAS HOSPITALIZED DUE TO HYPOGLYCEMIA. THE CUSTOMER STATED SHE DOES NOT REMEMBER ANY OF THE EVENTS THAT LED TO HER BEING HOSPITALIZED, ONLY THAT SHE BECAME UNCONSCIOUS WHILE AT THE STORE. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. THE INSULIN PUMP WAS READING THE RESERVOIR VOLUME ACCURATELY. THE CUSTOMER WAS ASSISTED WITH SETTING THE TIME BECAUSE IT WAS OFF BY ONE HOUR. THE CUSTOMER CALLED BACK DUE TO HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS NOT HOSPITALIZED DUE TO HYPERGLYCEMIA. TROUBLESHOOTING WAS PERFORMED AND THE PROGRAMMING WAS CORRECT. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. THE CUSTOMER STATED THAT SHE CHANGES THE INFUSION SETS EVERY THREE DAYS, BUT ONLY CHANGES THE RESERVOIR WHEN IT IS EMPTY. THE CUSTOMER WAS ADVISED TO CHANGE THE RESERVOIR EVERY THREE DAYS WITH THE INFUSION SET. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712LNAS PRDGM INS SK EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization