BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3945554 · Received July 21, 2014

    Report

    Report Number
    3004209178-2014-87856
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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

    ALL BUTTONS FUNCTION PROPERLY. PENDING FOR TESTING. INSULIN PUMP IS MONITORED. PENDING FOR TESTING. NO COSMETIC DAMAGE NOTED.

    Additional Manufacturer Narrative · 1

    ALL OF THE BUTTONS FUNCTIONED PROPERLY, NO KEYPAD ANOMALY NOTED AND NO DAMAGE ON THE LCD BOARD CONNECTOR NOTED. THE PUMP WAS MONITORED FOR 24 HOURS WITH MULTIPLE BASAL RATE AND PROGRAMED SEVERAL BOLUS UNITS; ALL BOLUS DELIVERY PROPERLY. NO BLACK SCREEN, BOLUS OR DISPLAY ANOMALY NOTED DURING OUR TESTING. NO COSMETIC DAMAGE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE NIGHT PRIOR TO THE PHONE CALL THEY SUSPENDED THE INSULIN PUMP IN ORDER TO TAKE A SHOWER. WHEN THEY RETURNED TO THE DEVICE IT WAS BLACK AND THE CUSTOMER COULD NOT PRESS ANY BUTTONS. THEY TOOK THE BATTERY OUT AND PUT IT BACK IN. AT FIRST THE DISPLAY WAS BLACK BUT THEN IT WENT BACK TO REGULAR SCREEN, BUT THE CUSTOMER COULD NOT BOLUS. THE SCREEN KEPT GOING TO BLACK. THE CUSTOMER'S BLOOD GLUCOSE WAS 131 MG/DL. THE DEVICE WAS NEITHER EXPOSED TO EXTREME TEMPERATURE NOR TO DIRECT SUNLIGHT. THE CUSTOMER WAS ADVISED TO STABILIZE THE DEVICE AT ROOM TEMPERATURE. THE CUSTOMER STATED THAT THE BLACK SCREEN DISAPPEARED. THE SELF TEST PASSED. THE CUSTOMER WAS ADVISED TO DO A 5 UNIT CANNULA TEST DURING WHICH THE SCREEN WENT BLACK AFTER DELIVERING ABOUT 0.6 UNITS, THEN THE SCREEN RETURNED AND WAS STILL COUNTING. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424686 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR