BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3973938 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88909
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH INTERMITTENT ACT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO FREEZING OR FROZEN DISPLAY NOTED. MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN ON THE CUSTOMER'S INSULIN PUMP WAS FREEZING AND THE BUTTONS ON HER PUMP WERE NOT WORKING AT TIMES. THE CUSTOMER WOULD PRESS THE ACT BUTTON, BUT THE SCREEN WOULD FREEZE AND OTHER TIMES, THE BUTTONS WOULD NOT RESPOND TO BEING PRESSED. HER BLOOD GLUCOSE WAS 98 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE AND REVERT TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451015 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR