BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP

    MDR report key: 6155029 · Received December 8, 2016

    Report

    Report Number
    2032227-2016-48470
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 11, 2016
    Report Date
    February 17, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. 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 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. (B)(4).

    Additional Manufacturer Narrative · 1

    AFTER BATTERY INSTALLATION, THE PUMP GAVE A STEADY WHITE DISPLAY DUE TO A CRACKED LCD CONTROLLER. NO BLANK DISPLAY WAS NOTED. UNABLE TO PERFORM FUNCTIONAL TESTING, INCLUDING THE SELF TEST, REWIND, SEATING, BASIC OCCLUSION, OCCLUSION, FORCE SENSOR AND DISPLACEMENT TESTS DUE TO THE DISPLAY ANOMALY. THE PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE LCD WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 108 MG/DL. DURING TROUBLESHOOTING, THE CUSTOMER REPLACED THE BATTERY SEVERAL TIMES AND THE DISPLAY DID NOT RETURN. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807236 640G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711H

    Patients

    Seq Age Sex Outcome Treatment
    1