BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5662129 · Received May 17, 2016

    Report

    Report Number
    3004209178-2016-49424
    Event Type
    Injury
    Date Received
    May 17, 2016
    Date of Event
    April 21, 2016
    Report Date
    April 29, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED ALL FUNCTIONAL TESTING, INCLUDING IDLE CURRENT TEST, RUN CURRENT TEST, SELF-TEST, OFF NO POWER TEST, UNEXPECTED RESTART ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/DELIVERY TEST, NO DELIVERY TEST, DISPLACEMENT TEST AND REWIND. INSULIN PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL OF FALLING AND DAMAGING INSULIN PUMP. DAMAGE WAS CAUSED TO DISPLAY SCREEN. CUSTOMER'S BLOOD GLUCOSE WAS 50 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR LOW BLOOD GLUCOSE AS IT WAS CORRECTED WITH FOOD. HEALTHCARE PROFESSIONAL RECOMMENDED THAT INSULIN PUMP BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313643 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other