BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751LNAL

    MDR report key: 8825320 · Received July 25, 2019

    Report

    Report Number
    2032227-2019-35805
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    May 28, 2019
    Report Date
    July 25, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169933200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH BLANK DISPLAY DUE TO CORRODED BATTERY TUBE SPRING CONTACT AND CORRODED BATTERY TUBE. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO BLANK DISPLAY. DEVICE RECEIVED WITH BROKEN BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE RESERVOIR LIP RING WAS NOT DAMAGED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619067 530G INSULIN PUMP MMT-751LNAL ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751LNAL A5751LNALJ 00643169933200

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR