BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2234058 · Received August 29, 2011

    Report

    Report Number
    2032227-2011-02194
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS. IT WAS STATED THAT THE CUSTOMER MAY HAVE ACCIDENTALLY PRIMED THE ENTIRE AMOUNT OF INSULIN IN THE RESERVOIR WHILE BEING CONNECTED. THE CUSTOMER WAS ATTEMPTING TO CHANGE THE INFUSION SET, AND PRIMED 150 UNITS OF INSULIN INTO HER BODY. THE REPORTED BLOOD GLUCOSE READING WAS 33 MG/DL. THE CALLER WANTED SOMEONE TO CALL THE CUSTOMER FOR TROUBLESHOOTING. ATTEMPTED TO REACH THE CUSTOMER BY PHONE, BUT THERE WAS NO ANSWER. LEFT TWO MESSAGES FOR THE CUSTOMER TO CALL BACK FOR TROUBLESHOOTING ON THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL NOT SPECIFIED INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization