BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3203475 · Received July 2, 2013

    Report

    Report Number
    2032227-2013-02710
    Event Type
    Death
    Date Received
    July 2, 2013
    Date of Event
    February 26, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP DID HAVE CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP AND CASE NEAR THE DISPLAY WINDOW CORNERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN HER SLEEP. THE CALLER STATED THAT THEY WENT TO DINNER THE NIGHT BEFORE, AND EVERYTHING WAS FINE. THE NEXT MORNING, THE CUSTOMER WAS FOUND UNCONSCIOUS, WITH BLOOD ALL OVER HER FACE. THE PARAMEDICS WERE CALLED, AND THE CUSTOMER'S BLOOD GLUCOSE WAS LOW WHEN THEY ARRIVED, BUT THE CALLER COULDN'T REMEMBER WHAT THE READING WAS. IT WAS STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH, AND IT WAS REMOVED WHEN SHE ARRIVED AT THE HOSPITAL. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301440 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death