BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3121987 · Received May 21, 2013

    Report

    Report Number
    2032227-2013-01879
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 28, 2013
    Report Date
    April 28, 2013
    Manufacturer
    MEDTRONIC MINIMED
    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. SEVERAL A47 ALARMS FOUND IN HISTORY FILE SCREEN, DUE TO CORRUPTED FILE. UNIT WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS, NO RATTLING NOISE NOTED WHEN SHAKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS UNKNOWN. CALLER STATED THAT THE CUSTOMER HAD A MAJOR SURGERY. CALLER STATED THAT THE CUSTOMER THREW THE INSULIN PUMP AGAINST THE HOSPITAL ROOM WALL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223694 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization