BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3990325 · Received August 7, 2014

    Report

    Report Number
    3004209178-2014-91276
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTIONED PROPERLY. NO FROZEN DISPLAY, AUDIO ANOMALY OR ALARM ICON ANOMALY WERE NOTED. THE TIME ADVANCED PROPERLY DURING TESTING. THE INSULIN PUMP PASSED THE SELF TEST AND THE DISPLACEMENT TEST. THE INSULIN PUMP COMMUNICATED PROPERLY WITH THE GLUCOSE SENSOR SIMULATOR AND THE MINILINK TRANSMITTER. NO SENSOR ERROR ALARM WAS NOTED. THE KEYPAD FLEX CONNECTOR WAS LOCKED. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED RESERVOIR TUBE LIP.

    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

    CUSTOMER REPORTED THAT THE INSULIN PUMP HAS AN ALARM BEEPING BUT NO ERROR MESSAGE IS SHOWN ON THE SCREEN. CUSTOMER ALSO STATED THAT THE KEYPAD IS NOT RESPONDING, THE DISPLAY IS NOT COMPLETELY BLANK AND THERE IS A BLACK CIRCLE ON THE DISPLAY SCREEN. CUSTOMER STATED THAT THE ALARM OCCURRED AT THE TIME THE BUTTONS WERE NOT WORKING. CUSTOMER STATED THAT THE BUTTONS BEGAN FUNCTIONING IN LESS THAN 5 MINUTES WITHOUT A BATTERY CHANGE BUT NOT ALL BUTTONS ARE RESPONDING. CUSTOMER STATED THE ALARM WAS SENSOR ERROR. THE DISPLAY WINDOW IS NOR FROZEN. BLOOD GLUCOSE LEVEL IS 160 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463390 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL A2751NALJ

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR