BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 15409176 · Received September 13, 2022

    Report

    Report Number
    2032227-2022-333735
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    July 18, 2022
    Report Date
    January 16, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    0000007630002835
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. THE INSULIN PUMP RECEIVED WITH PILLOWING KEYPAD OVERLAY AND CRACKED CASE BEHIND THE INSULIN PUMP AT THE BATTERY COMPARTMENT DURING THE VISUAL INSPECTION. THUS AND CARELINK SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. THE INSULIN PUMP PASSED 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 DELIVERY ACCURACY TEST AT 0.08680 INCHES. THE INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE 40 PIN FLEXIBLE PRINTED CIRCUIT/LCD, BATTERY TUBE, VIBRATOR AND J7, U28, J1 ON THE ELECTRICAL BOARD 1 AND J1 ON THE ELECTRICAL BOARD 2. THE FORCE SENSOR OFFSET MEASURED (24.4 MV). IN SUMMARY, THE INSULIN PUMP PASSED ALL REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR LOW BLOOD GLUCOSE. THE FORCE SENSOR IS WITHIN SPECIFICATION. MOISTURE DAMAGE ON THE 40 PIN FLEXIBLE PRINTED CIRCUIT/LCD, BATTERY TUBE, VIBRATOR AND J7, U28, J1 ON THE ELECTRICAL BOARD 1 AND J1 ON THE ELECTRICAL BOARD 2 DURING THE VISUAL INSPECTION.

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. INITIAL REPORT WAS SUBMITTED WITH MISSING INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER'S DAUGHTER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO LOW BLOOD GLUCOSE IN THE MONTH OF JUNE ON AN UNKNOWN DATE. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME OF HOSPITALIZATION WAS KNOWN. THE CUSTOMER DID NOT REPORT ANY SYMPTOMS SUCH AS A RESULT OF HIGH BLOOD GLUCOSE. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING AUTO MODE OR NOT. NO FURTHER COMPLICATIONS WERE REPORTED. TROUBLESHOOTING WAS NOT PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951269 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG418H4 0000007630002835

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization FRN-MMT-332-RSVR, UNOMED INF SET.