BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 10600599 · Received September 29, 2020

    Report

    Report Number
    2032227-2020-183959
    Event Type
    Death
    Date Received
    September 29, 2020
    Date of Event
    February 5, 2020
    Report Date
    October 14, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000090203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH A DEPLETED DURACELL ALKALINE BATTERY INSTALLED. DEVICE PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DELIVERY ACCURACY TEST AT 0.08700 INCHES. DEVICE UPLOADED PROPERLY USING CARE LINK. DEVICE HAD SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. (B)(4).

    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

    MEDTRONIC LEGAL RECEIVED INFORMATION REGARDING THE CUSTOMER¿S PASSING FROM THE ATTORNEY OF THE FAMILY. THE INFORMATION RECEIVED ON MARCH 25, 2020 STATED THE FOLLOWING - REPORTER ALLEGES: A CUSTOMER DEATH AND LEGAL ACTION BEING PURSUED. IT WAS EARLIER REPORTED THAT THE CUSTOMER WAS RIDING A SNOW MOBILE SOMEWHERE IN THE WESTERN UNITED STATES AND WAS FOUND LAYING FACE DOWN IN THE OVERNIGHT HOURS ON (B)(6) 2020. IT WAS LATER REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN A CABIN WHILE ON VACATION. THE CAUSE OF DEATH WAS HYPOGLYCEMIA. THE CALLER STATED THAT THE CUSTOMER HAD A HYPOGLYCEMIC INCIDENT AND A SEIZURE THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS BELOW 40 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT IS UNKNOWN IF THE AUTO MODE ON THE INSULIN PUMP WAS ACTIVE AND AUTOMATICALLY ADJUSTING INSULIN DELIVERY DURING THE EVENT. THE CUSTOMER WAS USING SENSORS. NO FURTHER INFORMATION WAS PROVIDED. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063099 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2LVYV 00763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death FRN-MMT-332, OZP-MMT-7020, UNOMED SET.