BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8662540 · Received June 3, 2019

    Report

    Report Number
    2032227-2019-10710
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 26, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    AFTER BATTERY INSTALLATION UNIT GAVE AN UNEXPECTED FLASHING WHITE / BLANK 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, DISPLACEMENT TEST OR VERIFY MISSING SEGMENTS/PARTIAL DISPLAY DUE TO DISPLAY ANOMALY. DEVICE RECEIVED WITH CRACKED CASE (BATTERY TUBE) AND CRACKED CASE-CORNER OF BELT CLIP RAILS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SCREEN WAS FLASHING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP WAS DROPPED AND HAD HAIRLINE CRACK ON THE BACK OF THE BATTERY COMPARTMENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO REPLACE AND 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
    456983 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2ZVDT 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR