BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6336866 · Received February 16, 2017

    Report

    Report Number
    3004209178-2017-90589
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    December 25, 2016
    Report Date
    January 31, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ON LCD BOARD. UNABLE TO PERFORM IDLE CURRENT TEST, RUN CURRENT TEST, SELF TEST, OFF NO POWER TEST, UNEXPECTED RESTART ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST, DISPLACEMENT TEST OR VERIFY BATTERY OUT LIMIT ALARM, WEAK BATTERY ALARM, BATTERY ICONS ANOMALY DUE TO BLANK DISPLAY. INSULIN PUMP HAD MINOR SCRATCHED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THE DEVICE HAD A BLANK DISPLAY. CUSTOMER'S BLOOD GLUCOSE WAS 170 MG/DL. DEVICE HAD ALARMED BATTERY OUT LIMIT ALARM AND WEAK BATTERY ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS' INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120460 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR