BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP

    MDR report key: 6098171 · Received November 12, 2016

    Report

    Report Number
    2032227-2016-41910
    Event Type
    Malfunction
    Date Received
    November 12, 2016
    Date of Event
    October 21, 2016
    Report Date
    February 14, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH A CONSTANT FLASHING WHITE LIGHT ON THE DISPLAY AND CONSTANTLY BEEPING DUE TO VERTICAL CRACKED LCD CONTROLLER. UNABLE TO PERFORM THE FUNCTIONAL TESTING, INCLUDING THE SELF-TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST DUE TO CONSTANT FLASHING WHITE LIGHT ON THE DISPLAY AND CONSTANTLY BEEPING. THE INSULIN PUMP RECEIVED WITH SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND MINOR SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED OF AN AUDIO/BEEP ANOMALY FROM THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE READING WAS UNKNOWN. THE CUSTOMER STATED THAT THE SCREEN IS BLACK AND WHITE AND FLASHES ALL THE TIME. THE CUSTOMER STATED THAT THE SWITCH IS ON AND OFF WITH AUDIO ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749018 640G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K

    Patients

    Seq Age Sex Outcome Treatment
    1