BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4850811 · Received June 17, 2015

    Report

    Report Number
    3004209178-2015-66086
    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 Location
    OH
    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 ALARMED BUTTON ERROR ALARM AND HAD AN UNRESPONSIVE BUTTON DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED CASE ON DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND SCRATCHES ON RESERVOIR TUBE WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP ALARM BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 181 MG/DL. THE CUSTOMER STATED THAT HE WENT TO BOLUS FOR MEAL AND NOTICED BUTTONS NOT WORKING THEN STARTED TO ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393080 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR