BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4133747 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-32024
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT HAD CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE, CRACKED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, AND A MISSING END CAP STICKER. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS PHYSICAL DAMAGE TO INSULIN PUMP. CUSTOMER STATES THAT INSULIN PUMP HAS A CRACK NEAR THE RIM OF THE RESERVOIR CHAMBER. CUSTOMER'S BLOOD GLUCOSE WAS 111 MG/DL. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611119 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR