BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4851979 · Received June 17, 2015

    Report

    Report Number
    3004209178-2015-66218
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 29, 2015
    Report Date
    May 29, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER'S SON REPORTED VIA PHONE, THE INSULIN PUMP HAD ALARMED BATTERY OUT LIMIT. CUSTOMER'S BLOOD GLUCOSE WAS 230 MG/DL. TROUBLESHOOTING WAS INITIATED FOR BATTERY OUT LIMIT BUT WAS SHIFTED TO KEYPAD ANOMALY DUE THE KEYPAD ON THE DEVICE WAS LOCKED AND UNRESPONSIVE. THE CUSTOMER'S SON STATED THEY CHANGED THE BATTERY, AND THE NEW BATTERY WAS INSERTED INCORRECTLY. THEY FLIPPED IT AROUND NOW IT'S NOT WORKING. CUSTOMER IS UNABLE TO CLEAR THE ALARM. CUSTOMER'S SON DOESN'T RECALL ANY SIGNIFICANT EVENTS WHICH MAY HAVE CAUSED THE KEYPAD ISSUES. CUSTOMER'S SON WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, REVERT TO BACK UP PLAN, AND THE DEVICE NEED TO BE REPLACED. HE AGREED TO RETURN HE DEVICE TO UNDERGO FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393827 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR