BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4150304 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34301
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    April 8, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY DUE TO THE BATTERY TUBE CONNECTOR NOT PLUGGED IN PROPERLY TO INTERFACE BOARD. UNABLE TO VERIFY BATTERY OUT LIMIT AND FAILED BATTERY TEST ALARM DUE TO BLANK DISPLAY. ALSO RECEIVED WITH A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BLANK DISPLAY ON HER INSULIN PUMP. THE CUSTOMER ALSO STATED THE INSULIN PUMP HAD A BLACK CIRCLE ON THE SCREEN. CUSTOMER'S BLOOD GLUCOSE WAS 145 MG/DL. SHE ALSO REPORTED A BATTERY OUT LIMIT ALARM. AFTER CLEARING THE BATTERY OUT LIMIT ALARM, THE CUSTOMER RECEIVED A FAILED BATTERY TEST ALARM. THE CUSTOMER STATED SHE FREQUENTLY RECEIVES FAILED BATTERY TEST ALARMS. 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
    628631 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR