BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3180907 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-94874
    Event Type
    Death
    Date Received
    June 20, 2013
    Date of Event
    March 30, 2013
    Report Date
    June 15, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST AND THE DELIVERY VOLUME ACCURACY TEST AT 98.76% PERCENT. THE DEVICE WAS RECEIVED WITHOUT THE ORIGINAL BATTERY. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FATHER CALLED BACK TO RISE HIS CONCERN ON HIS SON'S DEATH. THE FATHER STATED THAT HE RECEIVED THE CORONER'S REPORT THAT SHOW HIS SON'S BLOOD GLUCOSE LEVEL WAS AT 60MG/DL AT THE TIME OF DEATH. THE FATHER BELIEVES THE INSULIN PUMP MALFUNCTIONED CAUSING HIS SON'S DEATH. THE FATHER STATED THAT IF MEDTRONIC HAS INFORMED HIS SON OF ALL THE PROBLEMS WITH THE INSULIN PUMP THAT HE MAY STILL BE ALIVE. THE CALLER WAS REFERRING TO THE RECENT FIELD ACTION LETTERS HE HAS RECEIVED. THE FATHER ALSO STATED THAT HE WILL LET THE ATTORNEYS DEAL WITH THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS INVOLVED IN A MOTORCYCLE ACCIDENT AND PASSED AWAY. IT WAS STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT TIME OF DEATH. THE MOTHER ADVISED THAT THE CORONER STATED THAT HIS SON MAY HAVE PASSED OUT BECAUSE HIS LOW BLOOD GLUCOSE AROUND 60MG/DL AT TIME OF DEATH. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279654 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death