BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2872724 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-91368
    Event Type
    Death
    Date Received
    December 13, 2012
    Date of Event
    November 3, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 PASSED AWAY, AND SHE WAS NOT WEARING THE INSULIN PUMP AT TIME OF DEATH. IT WAS STATED THAT SHE PASSED AWAY IN HER SLEEP DUE TO A CARDIO EVENT. THE CALLER MENTIONED THAT SHE WENT LOW, FELL INTO A COMA, AND SHE DID NOT WAKE UP IN THE MORNING. THE CALLER ALSO STATED THAT THE CAUSE OF DEATH PER DEATH CERTIFICATE WAS NATURAL, CARDIAC ARRHYTHMIA DUE TO CORONARY ARTERY DISEASE, AND OTHER CONDITIONS RELATED TO DIABETES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death