BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 20949937 · Received December 17, 2024

    Report

    Report Number
    2032227-2024-287922
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 20, 2024
    Report Date
    April 1, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORRODED PCBA 1, PCBA 2, FORCE SENSOR AND VIBRATOR ASSEMBLY. MOISTURE DAMAGE WAS FOUND ON THE MOTOR. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS TRIGGERED BY A PUMP ERROR 35 FATAL ALARM CONFIRMED IN THE HISTORY FILE AT 11/19/2024 15:44:17.000 AND AT 11/19/2024 15:54:00.000. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, STAINED SERIAL NUMBER LABEL, PILLOWING KEYPAD OVERLAY AND CORRODED BATTERY TUBE. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW FOR THE PUMP ERRORS/ALARMS NOTED 2 DAYS PRIOR TO THE EVENT DATE 20-NOV-2024 IN THE PUMP HISTORY FILE. 11/18/2024 20:04:00.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: LOSTSENSOR1ALERT (780). 11/19/2024 07:40:00.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: LOSTSENSOR1ALERT (780), 11/19/2024 10:55:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOSTSENSOR1ALERT (780), 11/19/2024 15:44:17.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BROKENFORCESENSORERROR (35), 11/19/2024 15:46:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOWBATTERYALERT (104), 11/19/2024 15:54:00.000 ALARMALERTNOTIFICATION (40). FAULTNUMBER: BROKENFORCESENSORERROR (35), 11/19/2024 16:02:01.000 BATTERYREMOVED (55), 11/19/2024 16:02:01.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84), 11/19/2024 16:02:19.000 BATTERYINSERTED (44), 11/19/2024 16:02:19.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58), 11/19/2024 16:02:37.000 BATTERYREMOVED (55), 11/19/2024 16:02:37.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). UNABLE TO TEST FOR LOST SENSOR ALERT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. FAILED BATTERY TEST ALARM WAS EXPECTED DUE TO THE CUSTOMER'S BATTERY INSERTED ON A BATTERY CHANGE DOES NOT HAVE SUFFICIENT VOLTAGE. PUMP ERROR 35 CONFIRMED IN THE HISTORY FILE DUE TO CORRODED FORCE SENSOR. UNEXPECTED LOW BATTERY ALERT WAS CONFIRMED DUE TO CORRODED ELECTRONIC ASSEMBLY AND CORRODED BATTERY TUBE. LOSTSENSOR1ALERT (780) UNKNOWN. PUMP ERROR 35 CONFIRMED IN THE HISTORY FILE. LOWBATTERYALERT (104) CONFIRMED DUE TO CORRODED FORCE SENSOR. FAILEDBATTTEST (58) NOT CONFIRMED. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO PUMP ERROR 35 ALARMS. PUMP ERROR 35 ALARM CONFIRMED DUE TO CORRODED FORCE SENSOR. NO CURRENT CODE/CATEGORY CONFIRMED (UNEXPECTED LOW BATTERY ALERT FOUND IN THE PUMP HISTORY FILE). 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

    SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. 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. 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. 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 PUMP ERROR 35 (A BROKEN FORCE SENSOR WAS DETECTED DURING SEATING OR REGULAR DELIVERY). THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1885. CUSTOMER REPORTED A CRITICAL PUMP ERROR OTHER THAN THE OPEN BOOK IMAGE ERROR OR CRITICAL PUMP ERROR 24. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP. MMT-1885 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267507 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 HG53XB9ZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Unknown