BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4926426 · Received July 20, 2015

    Report

    Report Number
    2032227-2015-22622
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    September 8, 2013
    Report Date
    June 29, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONDS DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS WERE NOTED DURING TESTING. DURING VISUAL INSPECTION NO MOISTURE DAMAGE WAS NOTED ON THE ELECTRONIC OR MOTOR ASSEMBLIES. THE FOLLOWING COSMETIC DAMAGE WAS NOTED ON THE DEVICE: MISSING END CAP STICKER, CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, AND MINOR SCRATCHES ON THE LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE, THE INSULIN PUMP HAD ALARMED BUTTON ERRORS. CUSTOMER'S BLOOD GLUCOSE WAS 135 MG/DL. THE ALARM DID NOT OCCUR AFTER THE DEVICE WAS EXPOSED TO MOISTURE. THE BUTTONS WEREN'T PRESSED FOR THREE MINUTES OR LONGER. CUSTOMER STATED AFTER A BIT SHE WAS ABLE TO CLEAR THE ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, REVERT TO BACK UP PLAN, AND THE DEVICE NEED TO BE REPLACED. SHE AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470384 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR