BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP

    MDR report key: 4871434 · Received June 26, 2015

    Report

    Report Number
    3004209178-2015-69019
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G 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

    THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED LOW BATTERY IN LESS THAN ONE WEEK AFTER THE BATTERY WAS CHANGED. A RED EXCLAMATION MARK APPEARED ON THE SCREEN AND NOTHING ELSE. THE INSULIN PUMP HAD A BLANK DISPLAY FOR LESS THAN A MINUTE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 7.4 MMOL/L. THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414056 640G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711H

    Patients

    Seq Age Sex Outcome Treatment
    1