BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4130662 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-96025
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE DOWNLOAD HISTORY FILE SHOWS ON 07/20/14 AT 22:29 A NORMAL BOLUS OF 0.500 UNITS WAS PROGRAMMED AND DELIVERED. THE BUTTON EVENT FILE WAS OVER WRITTEN. UNABLE TO VERIFY IF CUSTOMER MANUALLY PROGRAMMED THE BOLUSES. THE INSULIN PUMP WAS PROGRAMMED AND MONITORED FOR TWO DAYS WITH NO UNEXPECTED BOLUS DELIVERY NOTED. THE DEVICE THEN WAS PROGRAMMED WITH MULTIPLE TEST BOLUSES AND MONITORED. ALL THE BOLUSES DELIVERED PROPERLY AND WERE LISTED IN THE BOLUS HISTORY SCREEN. NO BOLUS ANOMALY OR HISTORY ANOMALY NOTED. THE UNIT DID FUNCTION PROPERLY DURING REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. ALL THE BUTTONS DID FUNCTION PROPERLY. HOWEVER, MOISTURE DAMAGE WAS FOUND ON KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS PROVIDED BECAUSE THE DEVICE EVALUATION CODES IN OUR FIRST FOLLOW UP REPORT WERE INCORRECT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING DIFFICULTIES WITH THE INSULIN PUMP. THE CUSTOMER RAN TESTS ON THE INSULIN PUMP AND EVERYTHING PASSED. THEY STATED THAT THE KEYPAD HAD DELAYED RESPONSE AND EVERY TIME THEY TRIED TO GO TO ONE MENU, THE DEVICE TOOK THEM TO ANOTHER MENU. WHILE TRYING TO DELIVER A BOLUS THE KEYPAD HAD DELAYED REACTION. THE EASY BOLUS BUTTON SOMETIMES AUTOMATICALLY APPEARED WITH A BOLUS ANOMALY. AT THE TIME OF THE PHONE CALL THE CUSTOMER'S BLOOD GLUCOSE WAS 150 MG/DL. WHILE CHECKING THE BOLUS HISTORY THE CUSTOMER STATED THAT THERE APPEARED TO BE A BOLUS DELIVERY THAT THE CUSTOMER DID NOT PROGRAM, AND AS A RESULT HAD LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT THERE HAVE BEEN BUTTON ERROR ALARMS, BUT, WHEN THE CUSTOMER TRIED CHECKING THE ALARM HISTORY THE BUTTONS DID NOT RESPOND. THE DISCONTINUATION OF THE INSULIN PUMP WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608191 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR