BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 18920031 · Received March 18, 2024

    Report

    Report Number
    2032227-2024-143970
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    March 8, 2024
    Report Date
    June 4, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000076300063926601
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08725 INCHES. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. THE PUMP WAS MONITORED FOR SEVERAL DAYS WITH A NEW TEST AA 1.5V BATTERY TO ENABLE THE PUMP TO CHARGE. A BATTERY SIMULATOR WAS USED AND CONTINUED TESTING. STILL, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. PUMP ERROR 15 ALARM (FILENUMBER 522 LINENUMBER 465) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2024 04:48:34.000 AND (B)(6) 2024 06:13:08.000 PUMP ERROR 4 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 03/08/2024 04:48:34.000. 03/08/2024 06:13:08.000. PUMP ERROR 4 ALARM AND PUMP ERROR 15 ALARM (FILENUMBER 522 LINENUMBER 465) WERE CONFIRMED, SUSPECTED ON HW. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 08-MAR-2024 IN THE FORMATTED HISTORY FILE.  LOSTSENSOR1ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 03/03/2024 06:18:00.000. 03/05/2024 06:18:00.000. 03/05/2024 23:58:00.000. 03/06/2024 06:03:00.000. 03/06/2024 06:43:00.000. 03/07/2024 06:33:00.000. 03/07/2024 12:40:00.000. LOSTSENSOR2ALERT (781) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 03/07/2024 12:56:00.000. SENSORERRORALERT (801) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 03/07/2024 15:21:56.000. 03/07/2024 15:56:54.000. 03/07/2024 19:46:56.000. 03/07/2024 20:21:57.000. 03/07/2024 22:06:56.000. 03/07/2024 22:41:55.000. 03/07/2024 23:11:57.000. 03/07/2024 23:47:04.000. 03/08/2024 00:21:58.000. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A 240 MG/DL GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO LOST SENSOR ALERT, SENSOR ERROR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS/ALERTS WERE NOTED. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 03/08/2024 04:56:05.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 03/08/2024 04:48:37.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 13-MAR-2024 AT 6:52:56 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE EVENT DATE OF 08-MAR-2024. UNABLE TO CHECK POWER DATA FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE ORIGINAL PCBA 2 WAS INSTALLED IN A TEST PCBA 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN A TEST PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN THE ORIGINAL PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE PUMP HAD AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS), SUSPECTED ON THE HW (PCBA 1/PCBA 2). THE MOLDING KNIT LINE DAMAGE (NEAR THE BELT CLIP PLATE) WAS ACCEPTABLE PER CASE ASSEMBLY COSMETIC SPECIFICATION, 10833007DOC. THE SC1 CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS), PUMP ERROR 4 ALARM AND PUMP ERROR 15 ALARM (FILENUMBER 522 LINENUMBER 465) WERE CONFIRMED, SUSPECTED ON HW. 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. 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 OUTSIDE THE UNITED STATES. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED THAT THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO (PUMP ERROR 15 ALARM). TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM. THE CUSTOMER RECEIVED A REQUEST TO REWIND THE PUMP AND WAS ABLE TO COMPLETE THE PUMP REWIND. THE TIMING OF THE PUMP ERROR ALARM DURING THE BASAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS INSTRUCTED TO REVERT TO THE BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTION AND THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027582 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 NG3495801H 000076300063926601

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Unknown