BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 19678751 · Received July 5, 2024

    Report

    Report Number
    2032227-2024-197724
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    June 14, 2024
    Report Date
    October 1, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300063923501
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08750 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP AND CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY ON THE EVENT DATE OF 14-JUN-2024 FOUND NO BOLUS DELIVERY AND THE DAILY TOTAL OF BOLUS INSULIN DELIVERED ARE 0 U. IN FURTHER ANALYSIS OF THE DETAILED TRACE ON THE EVENT DATE 14-JUN-2024 THE PUMP WAS NOT IN THE CLOSED LOOP AND AUTO CORRECTION BOLUS WAS NOT DELIVERED. AND HERE IS THE REASON: ON (B)(6) AT 4:32PM THE USER (AS PER KEYPRESSES) DELETED CGM DEVICE FROM THE PUMP NETWORK LIST, PUMP EXITED CLOSED LOOP AND NEVER ENTERED AFTER JUNE 11TH PER R&D ANALYSIS. (B)(6) 2024 16:32:59.000 NETWORKDEVICEADDREMOVE (10). EVENTTYPE = 10. SOURCEID = 128. HISTORYRECORDLENGTH = 34. SYSTEMTIME = 06/11/2024 16:32:59.000. ACTION: DEVICEREMOVEDFROMNGPNETWORK (1). TOTALNUMBEROFNETWORKDEVICES: 2. SOURCEIDBEINGADDEDREMOVED: 13. SERIALNUMBERSTRING: (B)(6). 6/11/2024 16:32:59.000 ALARMALERTNOTIFICATION (40). EVENTTYPE = 40. SOURCEID = 0. HISTORYRECORDLENGTH = 29. SYSTEMTIME = 06/11/2024 16:32:59.000. FAULTNUMBER: CL1OPENLOOPALERT (820). LINENUMBER: 3869. FILENUMBER: (B)(4). 06/11/2024 16:32:59.000 CL1AUTOMATICTRANSITION (223). EVENTTYPE = 223. SOURCEID = 0. HISTORYRECORDLENGTH = 13. SYSTEMTIME = 06/11/2024 16:32:59.000. CL1TRANSITION: OUTOFCL1ACTIVE (0). REASONFORCL1AUTOMATICTRANSITION: OUTOFCL1ACTIVEDUETOUSEROVERRIDE (1). THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A 240 MG/DL GLUCOSE SENSOR SIMULATOR. THE PUMP WAS THEN PROGRAMMED FOR SMARTGUARD. THE PUMP SENSOR FEATURE AND THE SMARTGUARD ARE WORKING PROPERLY. NO SENSOR RELATED ERRORS OR ANOMALIES WERE NOTED. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.0 MV). THE SC1 CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: NO COSMETIC DAMAGES. THE PUMP PASSED ALL THE REQUIRED TESTING. CUSTOMER ALLEGED FOR NO AUTO CORRECTION BOLUS ON SMARTGUARD AND POSSIBLE UNDER DELIVERY ANOMALY WERE NOT CONFIRMED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    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. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED OUTSIDE THE UNITED STATES. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED POSSIBLE UNDER DELIVERY ANOMALY. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1886. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. PRODUCT RETURN STATUS FOR MMT-1886 IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447940 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 NG3606270H 000076300063923501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown