BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4193026 · Received October 22, 2014

    Report

    Report Number
    2032227-2014-41770
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM. THE INSULIN PUMP HAS MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND 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. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BUTTON ERROR ALARM. HE ALSO STATED ALL HIS BUTTONS WERE UNRESPONSIVE, EXCEPT FOR THE UP ARROW. THE CUSTOMER'S BLOOD GLUCOSE WAS 264 MG/DL. THE CUSTOMER COULD NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ALARM. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671402 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR