BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 7831133 · Received August 29, 2018

    Report

    Report Number
    2032227-2018-20729
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    August 6, 2018
    Report Date
    November 22, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00643169939219
    Adverse Event
    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 HAD UNRESPONSIVE BLANK SCREEN DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. THE MOTOR HAD MOISTURE DAMAGE. UNABLE TO PERFORM DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT TEST, ACTIVE CURRENT TEST, SELFTEST AND DISPLACEMENT ACCURACY TEST DUE TO UNRESPONSIVE BLANK DISPLAY. PUMP RECEIVED WITH CRACKED CASE ON THE BACK AT THE BATTERY TUBE AREA. THE INFORMATION PROVIDED IN CONCOMITANT REPORTING SECTION WITH THE INITIAL REPORT WAS INCORRECT. THE CORRECT INFORMATION HAS BEEN INCLUDED WITH THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WENT TO EMERGENCY ROOM BECAUSE OF LOW BLOOD GLUCOSE LEVEL OF 24 MG/DL. THE CUSTOMER¿S EXPERIENCED DIFFERENT BLOOD GLUCOSE LEVEL 254, 197 MG/DL. THE CUSTOMER WAS TREATED WITH FOOD FOR LOW BLOOD GLUCOSE AND MANUAL INJECTION FOR HIGH BLOOD GLUCOSE. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP STOPPED WORKING DUE TO MOISTURE EXPOSURE. TROUBLESHOOTING WAS NOT PERFORMED FOR LOW BLOOD GLUCOSE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670996 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG1UQ8M 00643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization