BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751NAH

    MDR report key: 7684178 · Received July 12, 2018

    Report

    Report Number
    3004209178-2018-90950
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    May 8, 2018
    Report Date
    July 12, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT HAD INTERMITTENT BUTTONS RESPONSE DUE TO FLATTENED (CREASED) UP BUTTON DOME SWITCH. NO UNLOCKED J2/LCD KEYPAD CONNECTOR NOTED. HOWEVER, UNIT RECEIVED WITH ALL OPERATING CURRENTS WITHIN SPEC AND PASSED FUNCTIONAL TESTING INCLUDING THE REWIND TEST, SELF-TEST, A21 ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. UNIT COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYS THE 100 VALUE PROPERLY ON DISPLAY GRAPH. THE SENSOR FEATURE WORKING PROPERLY. NO UNEXPECTED CALIBRATES ANOMALY OR SENSOR ALARMS ANOMALY NOTED. UNIT HAD CRACKED LCD WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S HIGH BLOOD GLUCOSE LEVEL WAS 292, 182, 277, 283, 89, 82, 180 MG/DL. THE CUSTOMER REPORTED THAT THERE WERE CRACKS ON LIQUID CRYSTAL DISPLAY SCREEN CONNECTING TO THE BODY. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE ALSO FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. THE CUSTOMER REPORTED THAT THEY HAD PERFORMED THE HIGH PRESSURE TEST AND THE TEST WAS PASSED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED AND ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522987 530G INSULIN PUMP MMT-751NAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH A4751NAHJ 00643169503687

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR