BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 1233933 · Received November 14, 2008

    Report

    Report Number
    2032227-2008-01958
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 4, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THAT SHE WAS TREATED BY PARAMEDICS FOR HYPOGLYCEMIA. THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE READING WAS LESS THAN 1 MMOL/L. THE CUSTOMER REPORTED THAT PRIOR TO THE EVENT THE BATTERY IN THE INSULIN PUMP HAD BEEN DEPLETED, BUT SHE WAS NOT AWARE THAT THE INSULIN PUMP WAS WITHOUT POWER. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention