BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 8806760 · Received July 19, 2019

    Report

    Report Number
    2032227-2019-32849
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    July 11, 2019
    Report Date
    September 5, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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

    THE DEVICE WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. DEVICE RECEIVED WITH CRACKED CASE ON THE BACK AT THE BATTERY TUBE AREA, AND BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP HAD RECEIVED AN OPEN BOOK IMAGE ON THE INSULIN PUMP SCREEN. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 249 MG/DL. THE CUSTOMER REPORTED THAT SHE GOT IN THE POOL AND THE INSULIN PUMP STARTED TO ALARM AND SHOWED A PICTURE OF THE INSULIN PUMP WITH A BOOK. THERE WAS ALSO A LARGE CRACK ON THE BACK OF THE INSULIN PUMP. THE CUSTOMER WAS ASSISTED IN TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. SHE WAS ALSO ADVISED TO PUT THE INSULIN PUMP INTO STORAGE MODE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601296 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG22AJU 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR