BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4233725 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48947
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP RECEIVED WITH CRACKED CASE ON THE LCD DISPLAY WINDOW CORNERS, CRACKS ON THE BATTERY TUBE THREADS, CRACKS ON THE RESERVOIR TUBE LIP, SCRATCHES ON THE RESERVOIR TUBE WINDOW, AND CRACKS ON THE RESERVOIR TUBE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER HAD CRACKS NEAR BATTERY COMPARTMENT OF INSULIN PUMP. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715035 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LWWB

    Patients

    Seq Age Sex Outcome Treatment
    1