BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP

    MDR report key: 6097555 · Received November 11, 2016

    Report

    Report Number
    2032227-2016-41501
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 20, 2016
    Report Date
    March 7, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED CRITICAL PUMP ERROR NOTED DURING TESTING. DEVICE PASSED THE FULL FUNCTIONAL TEST INCLUDING THE DISPLACEMENT TEST, REWIND, PRIME/SEATING TEST, BASIC OCCLUSION TEST AND FORCE SENSOR TEST. SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT WITHIN SPECIFICATIONS. DEVICE PASSED SELF-TEST. POWER MANAGEMENT PARAMETERS GRAPH CONFIRMED THE UNLOADED VOLTAGE AND LOADED VOLTAGE WAS WITHIN SPEC RANGE. DEVICE RECEIVED WITH SCRATCHED CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN PUMP RECEIVED A CRITICAL PUMP ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. IT WAS REPORTED THAT DISPLAY SCREEN SHOWED A RED "X" ICON. IT WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748137 640G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K

    Patients

    Seq Age Sex Outcome Treatment
    1