BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4240601 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49867
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. NO DISPLAY RAMPING ON ITS OWN ANOMALY NOTED. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS. UNIT RECEIVED WITH SEVERELY SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    IT IS REPORTED THAT CUSTOMER EXPERIENCED KEYPAD ANOMALY. IT IS REPORTED THAT NUMBERS BEGIN RAMPING ON PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 76 MG/DL. CUSTOMER WAS ADVISED THAT INSULIN PUMP WILL BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723320 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1