BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5141297 · Received October 9, 2015

    Report

    Report Number
    2032227-2015-55568
    Event Type
    Malfunction
    Date Received
    October 9, 2015
    Date of Event
    September 24, 2015
    Report Date
    September 24, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE PUMP WAS RECEIVED WITH OPERATING CURRENTS WITHIN SPECS. THE PUMP PASSED SELF-TEST, ALARM ERROR TEST AND DISPLACEMENT TEST. HOWEVER, THE PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AND MOTOR ERROR ALARM DURING BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR SYSTEM. THE PUMP WAS RECEIVED WITH BLEEDING GLASS ON LCD BOARD, SCRATCHES ON LCD WINDOW, AND CRACKED BATTERY TUBE THREADS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF A BUTTON ERROR ALARM FROM THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT SHE WENT TO WASH HER FACE AND THE PUMP FELL OFF. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND TO REVERT TO A BACKUP PLAN PER HEALTH CARE PROVIDER'S INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671098 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 50 YR