BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4103617 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-25349
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE ESCAPE AND ACTIVATE BUTTONS DUE TO THE UNLOCKED KEYPAD CONNECTOR. UNABLE TO VERIFY THE BATTERY OUT LIMIT ALARM DUE TO THE UNRESPONSIVE BUTTONS. NO BLANK DISPLAY DURING TESTING. NO DAMAGE FOUND ON THE LCD ISOLATION TAPE NOTED. ALSO, THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW AND SCRATCHED CASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BATTERY OUT LIMIT ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 307 MG/DL. SHE HAD TREATED HER BLOOD GLUCOSE WITH A MANUAL INJECTION. THE CUSTOMER COULD NOT BE ASSISTED WITH CLEARING THE ALARM. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP NOW HAD A BLANK DISPLAY. SHE ALSO REPORTED THAT HER ESC AND ACT BUTTON WAS NOT RESPONDING. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TOT HE ALARM. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582415 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR