BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 5968979 · Received September 21, 2016

    Report

    Report Number
    3004209178-2016-79746
    Event Type
    Malfunction
    Date Received
    September 21, 2016
    Date of Event
    August 7, 2016
    Report Date
    September 1, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED CRACKED CASE AT DISPLAY WINDOW CORNER. DEVICE RECEIVED WITH CRACKED BATTERY TUBE THREADS. DEVICE RECEIVED WITH BROKEN RESERVOIR TUBE LIP. INSULIN PUMP RECEIVED WITH MISSING RESERVOIR TUBE O-RING. DEVICE RECEIVED WITH CRACKED CASE AT RESERVOIR TUBE WINDOW CORNER. TEST RESERVOIR DOES NOT LOCK PROPERLY INSIDE THE RESERVOIR TUBE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THE ROUND PLASTIC ON THE RESERVOIR COMPARTMENT HAD BROKEN OFF. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS' INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620451 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR