BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 10400291 · Received August 13, 2020

    Report

    Report Number
    2032227-2020-162075
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    August 9, 2020
    Report Date
    September 14, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000643169939219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH CRITICAL PUMP ERROR AND UNABLE TO DOWNLOAD DUE TO CORRODED ELECTRONIC ASSEMBLIES. UNABLE TO VERIFY PUMP ERROR 35 DUE TO DOWNLOAD DIFFICULTY. UNABLE TO PERFORM SELF TEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST OR DISPLACEMENT TEST DUE TO CRITICAL PUMP ERROR. DEVICE RECEIVED WITH CORRODED BATTERY TUBE AND CORRODED MOTOR HOME SWITCH.

    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. MEDTRONIC, INC.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRITICAL PUMP ERROR. CUSTOMER WAS ON THE BEACH AND EVENTUALLY GOT THE ERROR MESSAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869237 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG28PJK 000000643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR