BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3223126 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-95599
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 26, 2013
    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

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST, AND THE DEVICE WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A PROTRUDED/LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED WHILE REFILLING A RESERVOIR AND INSULIN SQUIRTED OUT CONTINUOUSLY. THE BLOOD GLUCOSE READING WAS 140MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322923 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR