BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3120963 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93797
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS DUE TO MOTOR ERROR ALARM.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING IS 214 MG/DL. CUSTOMER HAS TREATED WITH MANUAL INJECTIONS. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 978 MG/DL. CUSTOMER EXPERIENCED VOMITING AND NAUSEA. DIAGNOSIS WAS DIABETIC KETOACIDOSIS. DURING TROUBLESHOOTING, TIME AND DATE ARE CORRECT. PROGRAMMING IS CORRECT. MANUAL PRIME IS CORRECT, INSULIN EXITED THE TUBING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221863 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization