BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103633 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25374
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    July 11, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTIONED PROPERLY. HOWEVER, FOUND CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARMS WERE NOTED DURING TESTING. THE PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNER, A BROKEN BELT CLIP SLOT, A CRACKED CASE, A MISSING END CAP STICKER AND A LOOSE / PROTRUDED DRIVE SUPPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED FOR A BUTTON ERROR. THE BLOOD GLUCOSE READING WAS NOT PROVIDED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581764 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-554WWL

    Patients

    Seq Age Sex Outcome Treatment
    1