BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8846100 · Received July 31, 2019

    Report

    Report Number
    2032227-2019-39029
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 20, 2019
    Report Date
    September 23, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    DEVICE WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. UNABLE TO PERFORM THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND, PRIME/SEATING TEST, BASIC OCCLUSION, OCCLUSION, FORCE SENSOR AND DISPLACEMENT TEST DUE TO THE CRITICAL PUMP ERROR. UNABLE TO DOWNLOAD DUE TO MOISTURE DAMAGED ON ELECTRONIC ASSEMBLY. UNABLE TO VERIFY PUMP ERROR 35 DUE TO DOWNLOAD DIFFICULTIES

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BROKEN FORCE SENSOR ALARM. THE BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTHCARE PROFESSIONAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639220 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2542P 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR