BEUDAMED
    FDA Adverse Event Death Summary report: N

    LANCET DEVICE MMT-395 QCKSRTR M4 13L

    MDR report key: 2161146 · Received July 8, 2011

    Report

    Report Number
    2032227-2011-01654
    Event Type
    Death
    Date Received
    July 8, 2011
    Date of Event
    November 3, 2010
    Report Date
    June 23, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    KZH
    PMA / PMN Number
    K992300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSE OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. PLEASE SEE ALSO MFR REPORT NUMBER 3004209178-2011-82059.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY DUE TO ACUTE RESPIRATORY FAILURE AND DIABETIC COMA. THE CALLER STATED THAT SHE NOTICED INSULIN ALL OVER THE CUSTOMER'S PANTS WHEN HE WAS BEING TAKEN TO THE HOSPITAL BY PARAMEDICS. THE CALLER DID NOT HAVE THE INSULIN PUMP WITH HER, BUT SHE AGREED TO RETURN THE SUPPLIES FOR ANALYSIS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANCET DEVICE MMT-395 QCKSRTR M4 13L ACCESSORIES KZH MEDTRONIC MINIMED MMT-395

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death