BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12629331 · Received October 14, 2021

    Report

    Report Number
    2032227-2021-205091
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    October 7, 2021
    Report Date
    November 22, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000090203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021 THE CUSTOMER ALLEGED WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. DEVICE RECEIVED WITH PILLOWING KEYPAD OVERLAY, FADED SERIAL NUMBER LABEL AND CRACKED SELECT BUTTON KEYPAD OVERLAY DURING THE VISUAL INSPECTION. THUS AND CARELINK SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. DEVICE PASSED THE SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DELIVERY ACCURACY TEST AT 0.08730 INCHES. HOWEVER, INSULIN PUMP RECEIVED WITH SAME AUDIO TONE WHEN SWITCHING FROM VOLUME 5 TO VOLUME 1 AND PUMP ERROR 63 ALARM DURING THE SELF TEST AND CONFIRMED IN THE DEVICE HISTORY (VARIABLEINFO=3) AT (B)(6) 2021 ON 15:19:53 AND (B)(6) 2021. PERFORM THE SELF TEST AND PUMP ERROR 63 ALARM AND SAME AUDIO TONE WHEN SWITCHING FROM VOLUME 5 TO VOLUME 1 NOTED. THE ORIGINAL ELECTRICAL BOARD 1 WAS INSTALLED IN A TEST ELECTRICAL BOARD 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE INSULIN PUMP ON USING THE BATTERY SIMULATOR AND PUMP ALARMED PUMP ERROR 63. THE ORIGINAL ELECTRICAL BOARD 2 WAS INSTALLED IN A TEST ELECTRICAL BOARD 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE INSULIN PUMP ON USING THE BATTERY SIMULATOR AND NO PUMP ERROR 63 ALARM AND INCREASED/DECREASED VOLUME WITH THE AUDIO FEATURE FUNCTIONING PROPERLY NOTED. THE FORCE SENSOR OFFSET MEASURED (22.0 MILIVOLTS). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NEXT GENERATION INSULIN PUMP STB3 AND PASSED. IN SUMMARY, INSULIN PUMP ALARMED PUMP ERROR 63 DURING THE SELF TEST AND THE SAME AUDIO TONE WHEN SWITCHING FROM VOLUME 5 TO VOLUME 1 SUSPECTED TO BE ON ELECTRICAL BOARD 1. UNABLE TO VERIFY CUSTOMER COMPLAINT FOR HIGH BLOOD GLUCOSE. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE 600 MG/DL ON (B)(6) 2021. THE CUSTOMER'S CURRENT BLOOD GLUCOSE IS 103 MG/DL. THE CUSTOMER EXPERIENCED DIABETIC KETOACIDOSIS. THE CUSTOMER WAS TREATED WITH NORMAL PUMP AT THE HOSPITAL THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527570 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2GLLB 000000763000090203

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization FRN-MMT-332A-RSVR, UNOMED SET| FRN-MMT-332A-RSVR, UNOMED SET