BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8643300 · Received May 27, 2019

    Report

    Report Number
    2032227-2019-06943
    Event Type
    Malfunction
    Date Received
    May 27, 2019
    Date of Event
    May 22, 2019
    Report Date
    July 25, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED WITH A CONSTANT BLANK FLASHING WHITE LIGHT ON THE DISPLAY FOLLOWED BY AN UNEXPECTED INTERMITTENT BEEP ALARM DUE TO VERTICAL CRACKED LCD CONTROLLER. UNABLE TO PERFORM THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, AND THE DISPLACEMENT TEST OR VERIFY MISSING SEGMENTS/PARTIAL DISPLAY DUE TO DISPLAY ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SCREEN HAD FLASHING DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE WAS 6 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE WHITE FLASHING SCREEN AND BATTERY CAP METAL PIECE CAME OFF. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437664 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG224CV 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR