BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2232458 · Received August 25, 2011

    Report

    Report Number
    2032227-2011-02165
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 11, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 DIABETES CARE PUBLISH AHEAD OF PRINT WAS PUBLISHED THAT ON (B)(6), 2011, A (B)(6) GIRL USING AN INSULIN PUMP, HAD DEVELOPED RECURRENT HYPOGLYCEMIA 60 TO 90 MINUTES AFTER A COMMERCIAL AIRPLANE TOOK OFF. THE ARTICLE REPORTED THAT 50 USERS, CHILDREN AND ADULTS USING THE INSULIN PUMP HAVE EXPERIENCED HYPOGLYCEMIA. THE ARTICLE STUDIED THE EFFECTS OF ATMOSPHERE PRESSURE ON INSULIN PUMP DELIVERY.

    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 Hospitalization