BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3100707 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-93230
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH PRIME ALARM DURING BASIC OCCLUSION TEST AND UNABLE TO PRIME DURING PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE INSULIN PUMP IS STUCK IN THE PRIME LOOP AND INSULIN IS SQUIRTING OUT. CUSTOMER'S BLOOD GLUCOSE READING IS 123 MG/DL. CUSTOMER STATED THAT THE DRIVE SUPPORT DISK IS PROTRUDING. ADVISED CUSTOMER THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200404 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 18 YR