BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3192802 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-95103
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 8, 2013
    Report Date
    June 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM DURING THE BASIC OCCLUSION TEST AND PRIME ALARM DURING THE PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. MOTOR PASSED MOTOR TEST. UNABLE TO PERFORM THE EXCESSIVE NO DELIVERY AND OCCLUSION TEST DUE TO MOTOR ERROR AND PRIME ALARM. THE INSULIN PUMP WAS MONITORED FOR SEVERAL DAYS AND NO ALARM NOTED. THE INSULIN PUMP PASSED THE ERROR TEST. NO ALARM NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING PRIME. CUSTOMER'S BLOOD GLUCOSE READING IS 509 MG/DL. CUSTOMER STATED THAT INSULIN SQUIRTS OUT DURING MANUAL PRIME PROCESS. ADVISED THAT INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291772 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR