BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982349 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90095
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED MOTOR ERROR DURING THE OCCLUSION TEST AND UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. MOTOR PASSED MOTOR TEST. INSULIN PUMP RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT AND MINOR SCRATCHES ON DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED HAVING A MOTOR ERROR ALARM. CUSTOMER DOES NOT USE THE SENSOR FEATURE. THE BLOOD GLUCOSE READING IS 255 MG/DL. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE PUMP. NOTHING FURTHER REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING A MOTOR ERROR ALARM. CUSTOMER DOES NOT USE THE SENSOR FEATURE. THE BLOOD GLUCOSE READING IS 255 MG/DL. ADVISED CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458382 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR