BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751NAB

    MDR report key: 7266422 · Received February 13, 2018

    Report

    Report Number
    3004209178-2018-50380
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    September 3, 2017
    Report Date
    February 19, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169404304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP HAD BLANK DISPLAY DUE TO MOISTURE DAMAGE ON LCD BOARD. UNABLE TO PERFORM IDLE CURRENT TEST, RUN CURRENT TEST, SELF TEST, OFF NO POWER TEST AND DISPLACEMENT TEST DUE TO BLANK DISPLAY. PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 82 MG/DL. THE DISPLAY RETURN AFTER TROUBLESHOOTING. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111440 530G INSULIN PUMP MMT-751NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB A2751NABJ 00643169404304

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR