BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL NOT SPECIFIED

    MDR report key: 2870030 · Received December 12, 2012

    Report

    Report Number
    2032227-2012-07984
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS. THE CALLER STATED THAT THE INFUSION SET HAD TO BE REMOVED FROM THE CUSTOMER, BUT THE CUSTOMER DID NOT HAVE ANOTHER ONE TO USE. THE CALLER REQUESTED EMERGENCY SUPPLIES TO BE SENT TO THE HOSPITAL. THE CALLER DID NOT HAVE ANY OF THE CUSTOMER'S INFORMATION AT THE TIME OF THE CALL. THE CALLER WAS TRANSFERRED TO THE PROPER DEPARTMENT FOR EMERGENCY SUPPLIES. 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