BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4770997 · Received May 14, 2015

    Report

    Report Number
    3004209178-2015-56105
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    February 5, 2015
    Report Date
    April 23, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    THE INSULIN PUMP WAS RECEIVED WITH CRACKED AND BLEEDING LCD GLASS. THE DEVICE HAD MINOR SCRATCHES ON THE LCD WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP HAD BROKEN BATTERY COMPARTMENT THREADS. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP IS RETURNING FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315125 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWS

    Patients

    Seq Age Sex Outcome Treatment
    1