BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3100524 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-93225
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM BASIC OCCLUSION, OCCLUSION, EXCESSIVE NO DELIVERY ALARM TESTS DUE TO PRIME/FILL ANOMALY. HOWEVER, UNIT PASSED THE DISPLACEMENT TEST, NO MOTOR ERROR ALARMED OCCURRED MOTOR TESTED OK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS UNKNOWN. CUSTOMER STATED THAT SHE HAD A DIABETIC STROKE AND THAT THE ULTRASOUNDS FOUND A CLOT IN THE RIGHT SIDE OF THE BRAIN. CUSTOMER STATED THAT THE INSULIN PUMP WAS VIBRATING AND ALARMING PRIOR TO GOING TO THE HOSPITAL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200275 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization