BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2802157 · Received October 23, 2012

    Report

    Report Number
    3004209178-2012-90314
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. THE DEVICE HAD CRACKED CASE ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INSULIN SQUIRTED OUT AND THE NUMBERS DID NOT APPEAR ON THE SCREEN WHILE PRIMING THE DEVICE. THE CUSTOMER CHANGED THE INFUSION SET TWICE WITHOUT RESULTS. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE INSULIN PUMP. 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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR