BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3230551 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-95767
    Event Type
    Death
    Date Received
    July 16, 2013
    Date of Event
    March 21, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY WHILE NOT WEARING THE INSULIN PUMP. IT WAS STATED THAT THE CUSTOMER CAME HOME WITH HIGH BLOOD GLUCOSE ABOUT 5:15 TO 5:30 PM AND TOOK OFF THE INSULIN PUMP, AND THEN HE WENT OUTSIDE. THREE HOURS LATER THE WIFE FOUND HIM AND THE CUSTOMER RAN OVER BY AN EQUIPMENT. THE WIFE BELIEVES THAT HE HAD DIED A WHILE BEFORE SHE FOUND HIM. THE SPOUSE STATED THAT SHE IS NOT SURE IF THE CUSTOMER COULD HAVE BOTTOMED OUT OR WHAT HAPPENED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329556 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death