BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6107781 · Received November 16, 2016

    Report

    Report Number
    2032227-2016-42389
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    November 10, 2016
    Report Date
    December 12, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 PUMP WAS RECEIVED WITH NO BUTTON RESPONSE DUE TO AN UNLOCKED CONNECTOR ON THE LCD BOARD. NO AUDIO/BEEP ANOMALY OR FROZEN DISPLAY WAS NOTED. UNABLE TO PERFORM ANY TESTS DUE TO UNRESPONSIVE BUTTONS. THE PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL TO HAVE EXPERIENCED A LOUD CONSTANT TONE OF INSULIN PUMP. CUSTOMER CHANGED BATTERIES AND CONSTANT TONE WAS NOT RESOLVED. TROUBLESHOOTING COULD NOT BE PERFORMED AS INSULIN PUMP ALSO HAD A BLANK DISPLAY SCREEN. CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. CUSTOMER'S BLOOD GLUCOSE WAS 112 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758225 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR