BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2436596 · Received January 30, 2012

    Report

    Report Number
    3004209178-2012-84834
    Event Type
    Death
    Date Received
    January 30, 2012
    Date of Event
    December 31, 2011
    Report Date
    January 4, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. PLEASE SEE ALSO MFR REPORT NUMBER 3004209178-2012-84833.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. WIFE STATED THAT HE WAS OUT SNOWMOBILING AND HE WAS WEARING THE INSULIN PUMP WHEN HE PASSED AWAY. WIFE REPORTED THAT THE CAUSE OF DEATH WAS A BLUNT FORCE TRAUMA. SHE ALSO STATED THAT THE CUSTOMER BLOOD GLUCOSE WAS 71 MG/DL PRIOR TO LEAVING THE HOUSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 1.8 ML FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET