BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 5092858 · Received September 21, 2015

    Report

    Report Number
    2032227-2015-46980
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    August 31, 2015
    Report Date
    September 1, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO CORRODED ELECTRONIC ASSEMBLIES ALSO, THE INSULIN PUMP HAS CORRODED MOTOR HOME SWITCH AND CORROSION WAS NOTED AT KEYPAD TRACES. UNABLE TO VERIFY UNRESPONSIVE BUTTONS DUE TO BLANK DISPLAY. THE INSULIN PUMP HAS MINOR SCRATCHES ON THE LCD WINDOW AND CRACKED BATTERY TUBE THREADS.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA PHONE CALL, THAT THE BUTTONS ON THE INSULIN PUMP ARE UNRESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 200 MG/DL. TROUBLESHOOTING OCCURRED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP, AND REVERT TO A BACK-UP 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
    623269 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR