BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3191779 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-95064
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    January 4, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS, BUT THE CUSTOMER WAS DISCONNECTED DURING PRIME. IT WAS STATED THAT THE PISTON CONTINUES MOVING FORWARD AFTER THE RESERVOIR MAKES CONTACT AND INSULIN SQUIRTS OUT. IT WAS MENTIONED THAT THE NUMBERS DID NOT APPEAR ON THE SCREEN, AND THE BEEPS COULD NOT BE HEARD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290484 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522WWB

    Patients

    Seq Age Sex Outcome Treatment
    1