BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4854863 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-66601
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 30, 2015
    Report Date
    June 30, 2015
    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

    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.

    Additional Manufacturer Narrative · 1

    NO FROZEN DISPLAY ANOMALY NOTED. NO UNRESPONSIVE BUTTONS NOTED. ALL OF THE BUTTONS FUNCTION PROPERLY. NO MOISTURE DAMAGE OR CORRODED KEYPAD TRACES NOTED. NO UNLOCKED CONNECTOR AT THE LCD BOARD. THE INSULIN PUMP WAS CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD ISSUES WITH THE KEYPAD ON THEIR INSULIN PUMP AFTER RECEIVING A BLANK DISPLAY SCREEN. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 126 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT THE BUTTONS DO NOT RESPOND. THE CUSTOMER STATED THAT THEY TOOK THE BLOOD GLUCOSE READING FROM THE METER TO TRANSFER THE DATA WHEN THE SCREEN OF THE INSULIN PUMP FROZE. THE CUSTOMER WAS ASSISTED WITH THE ISSUE AND WAS INFORMED THAT THE PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK UP PLAN. THE CUSTOMER SENT THE PRODUCT BACK FOR ANALYSIS. A REPLACEMENT PUMP WAS SHIPPED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396369 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR