BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6111311 · Received November 17, 2016

    Report

    Report Number
    2032227-2016-43019
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 23, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE BUTTONS DUE TO UNLOCKED LCD KEYPAD CONNECTOR. UNABLE TO PERFORM ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT ,OPERATING CURRENTS, A21 ERROR TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST DUE TO UNRESPONSIVE BUTTONS. THE INSULIN PUMP HAD MINOR SCRATCHED LCD WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND BROKEN RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THE ESC BUTTON WAS UNRESPONSIVE. CUSTOMER'S BLOOD GLUCOSE WAS 45 MG/DL. CUSTOMER TREATED WITH ORANGE JUICE AND GRANOLA BAR. 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
    761338 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other