BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP

    MDR report key: 5194012 · Received November 1, 2015

    Report

    Report Number
    2032227-2015-61577
    Event Type
    Malfunction
    Date Received
    November 1, 2015
    Date of Event
    October 12, 2015
    Report Date
    October 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PATIENT

    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).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THEY HAVE PROBLEM WITH DELIVERING BOLUS. CUSTOMER'S BLOOD GLUCOSE WAS 7.9 MMOL/L. WE HAVE CHECKED THE PROCEDURE OF BOLUS WIZARD AND EVERYTHING IS CORRECT. THE CUSTOMER HAS HIGH BLOOD GLUCOSE BECAUSE BOLUS IS NOT DELIVERED. THE CUSTOMER DOESN'T TRUST PUMP. THE CUSTOMER WAS ADVISED THAT WE WILL SEND REPLACEMENT VIA EOC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724286 640G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K

    Patients

    Seq Age Sex Outcome Treatment
    1