BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3223078 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-95591
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE BUTTONS DUE TO CORRODED KEYPAD TRACES. UNABLE TO PERFORM THE PRIME TEST BECAUSE THE BUTTONS WERE NOT RESPONDING. THE DEVICE WAS RECEIVED WITH PROTRUDED/LOOSE DRIVE SUPPORT DISK AND MISSING END CAP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS, AND THE DEVICE ALARMED. THE BLOOD GLUCOSE READING WAS 258MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. ASSISTED THE CUSTOMER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323605 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR