BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 5994621 · Received October 3, 2016

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    Report

    Report Number
    2032227-2016-25745
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    May 14, 2016
    Report Date
    September 1, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    P120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR ERROR ALARM DURING OCCLUSION TEST DUE TO FAULTY FORCE SENSOR RESISTOR. INSULIN PUMP PASSED IDLE CURRENT TEST, RUN CURRENT TEST, SELF-TEST, OFF NO POWER TEST, UNEXPECTED RESTART ERROR TEST, BASIC OCCLUSION TEST, DISPLACEMENT TEST, AND REWIND. UNABLE TO PERFORM PRIME/COMPROMISED FORCE SENSOR SYSTEM TEST AND NO DELIVERY TEST DUE TO MOTOR ERROR ALARM. INSULIN PUMP WAS RECEIVED WITH MISSING ADDRESS/SERIAL NUMBER LABEL, MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, AND BUTTON KEYPAD OVERLAY DAMAGED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BARCODE STICKER ON THE BACK OF THE INSULIN PUMP CAME OFF. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 380 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646843 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR