BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2870049 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-07986
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 17, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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'S FATHER CALLED TO REPORT THAT HIS DAUGHTER HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE LEVELS DURING THE NIGHT, AND HER HCP WOULD LIKE FOR HER TO GET ON THE CONTINUOUS GLUCOSE MONITOR. THE FATHER ALSO STATED THAT THE CUSTOMER HAS BEEN IN AND OUT OF THE HOSPITAL DUE TO LOW BLOOD GLUCOSE LEVELS. THE FATHER DID NOT PROVIDE ANY DATES OR DETAILS REGARDING THE HOSPITALIZATIONS. PROVIDED THE FATHER WITH THE EXTENSION TO THE CORRECT DEPARTMENT. 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 Hospitalization