BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2802129 · Received October 23, 2012

    Report

    Report Number
    3004209178-2012-90308
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED AN ERROR DURING THE PRIME TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. THE DEVICE WAS RECEIVED WITH MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED AN ERROR DURING MANUAL PRIME. ADVISED THE CALLER REVERT TO BACK UP PLAN UNTIL THE REPLACEMENT OF THE INSULIN PUMP ARRIVES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR