BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8761620 · Received July 3, 2019

    Report

    Report Number
    2032227-2019-24599
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    June 26, 2019
    Report Date
    August 26, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. UNABLE TO PERFORM THE SELF TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, AND ACTIVE CURRENT MEASUREMENT TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. MOISTURE DAMAGE WAS ALSO FOUND ON THE MOTOR AND FORCE SENSOR DURING VISUAL INSPECTION.

    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 RECEIVED A BOOK IMAGE ERROR MESSAGE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 165 MG/DL. CUSTOMER REPORTS THEY RECEIVED THE OPEN BOOK IMAGE ON THE INSULIN PUMP SCREEN. THE CUSTOMER ALSO REPORTED THAT THEY RECEIVED A REPLACE BATTERY ALERT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE CUSTOMER WAS ASSISTED IN TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555038 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG36P1C 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR