BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3898626 · Received June 26, 2014

    Report

    Report Number
    2032227-2014-03218
    Event Type
    Death
    Date Received
    June 26, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 23, 2014
    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

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TEST, INCLUDING PRIME, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TEST. UNIT WAS RECEIVED WITH RAYOVAC ALKALINE BATTERY. UNIT HAD CRACKED RESERVOIR TUBE LIP AND CASE NEAR DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. CALLER STATED THAT THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH, IT WAS REMOVED BEFORE PASSING. CALLER STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS 70 MG/DL AND HE DIED DUE TO DIABETES AND LIVER COMPLICATIONS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374024 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death