BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 5171694 · Received October 23, 2015

    Report

    Report Number
    2032227-2015-52309
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    October 3, 2015
    Report Date
    October 3, 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

    UNIT ALARMED A35 DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM DISPLACEMENT TEST AND VERIFY MOTOR ERROR DUE TO MOTION SENSOR TEST FAILURE ALARM. UNIT RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS AND BELT CLIP SLOT. UNABLE TO PERFORM OPERATING CURRENTS DUE TO MOTION SENSOR TEST FAILURE ALARM. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND MOTION SENSOR TEST FAILURE. CUSTOMER DOES NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 220 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS DONE FOR MOTOR ERROR AND FOUND THAT THE PUMP ALARMED MOTION SENSOR TEST FAILURE DURING REWIND AND WHEN THE BUTTONS ARE PRESSED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER DOCTOR'S INSTRUCTION. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701418 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR