BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP

    MDR report key: 6121344 · Received November 22, 2016

    Report

    Report Number
    2032227-2016-43675
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 28, 2016
    Report Date
    March 1, 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

    THE PUMP PASSED THE FULL FUNCTIONAL TESTS, INCLUDING THE DISPLACEMENT, REWIND, PRIME/SEATING, BASIC OCCLUSION AND FORCE SENSOR TESTS. THE SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT WAS WITHIN SPECIFICATIONS. NO UNEXPECTED PUMP ERROR 2 OR MOTOR ERROR ALARM WAS NOTED DURING TESTING. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND IT PASSED. THE PUMP WAS RECEIVED WITH A SCRATCHED CASE AND A DAMAGE KEYPAD OVERLAY TEXTURE.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED OF INTERPROCESSOR COMMUNICATION ERROR FROM THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE READING WAS UNKNOWN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771256 640G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712H

    Patients

    Seq Age Sex Outcome Treatment
    1