BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 6668924 · Received June 26, 2017

    Report

    Report Number
    2032227-2017-23756
    Event Type
    Malfunction
    Date Received
    June 26, 2017
    Date of Event
    June 1, 2017
    Report Date
    September 5, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169662612
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PARADIGM REAL-TIME 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

    THE INSULIN PUMP PASSED THE FUNCTIONAL TESTS, 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. PUMP ERROR ALARM FOUND IN THE PUMP HISTORY DUE TO SOFTWARE ERROR (ESF = 1852449) THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED SELECT BUTTON KEYPAD OVERLAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER RECEIVED A PUMP ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447516 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG0STK1 00643169662612

    Patients

    Seq Age Sex Outcome Treatment
    1