BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4822295 · Received June 5, 2015

    Report

    Report Number
    3004209178-2015-63034
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 17, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE FOUND ON THE ELECTRONICS, MOTOR, BATTERY TUBE, AND VIBRATOR. THE DEVICE HAD CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW, CRACKED BELT CLIP SLOT, AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP EXPERIENCED KEYPAD ISSUES. THE CUSTOMER STATED THE ACT BUTTON WAS WORKING INTERMITTENTLY AND THAT THE UP AND DOWN BUTTONS WERE NOT WORKING. THE CUSTOMER EXPLAINED THAT THE INSULIN PUMP WAS SCROLLING THROUGH EVERYTHING. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. WHILE TROUBLESHOOTING, THE CUSTOMER EXPLAINED THAT HE WAS RUNNING A MARATHON AND THAT SWEAT MAY HAVE COME INSIDE THE SCREEN. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER HEALTHCARE PROVIDER'S INSTRUCTIONS. THE CUSTOMER WAS INFORMED THE DEVICE WOULD BE REPLACED. THE CUSTOMER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365664 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR