BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4143726 · Received October 6, 2014

    Report

    Report Number
    2032227-2014-30564
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, BROKEN RESERVOIR TUBE LIP, MISSING O-RING, CRACKED RESERVOIR TUBE AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD PHYSICAL DAMAGE ON THE INSULIN PUMP. IT WAS ALSO REPORTED THAT THE CASING AT THE ENTRANCE OF THE RESERVOIR CHAMBER WAS BROKEN OFF HER SON'S INSULIN PUMP. INSULIN PUMP WILL NEED TO BE RETURNED FOR ANALYSIS AND WILL NEED TO BE REPLACED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624142 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522CAB

    Patients

    Seq Age Sex Outcome Treatment
    1