BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3903533 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86394
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED DURING THE PRIME TEST AS A RESULT OF A FLUSH/LOOSE DRIVE SUPPORT DISK. THE DEVICE WAS RECEIVED WITH CRACKED DISPLAY WINDOW CORNER, BATTERY TUBE THREADS, RESERVOIR TUBE LIP, BELT CLIP SLOT, AND SCRATCHED SCREEN.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE PRIME TEST DUE TO FLUSH/LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP RECEIVED WITH CRACKED DISPLAY WINDOW CORNER, BATTERY TUBE THREADS, RESERVOIR TUBE LIP, BELT CLIP SLOT AND SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED DURING PRIMING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379452 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWL

    Patients

    Seq Age Sex Outcome Treatment
    1