BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP 1886 780G OUS BLE PUMP MG/DL

    MDR report key: 19215037 · Received April 30, 2024

    Report

    Report Number
    2032227-2024-161474
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    April 16, 2024
    Report Date
    August 27, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384289
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP PASSED THE SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT. PUMP WAS MONITORED AND NO UNEXPECTED BATTERY POWER LOSS NOTED. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUMP. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE LOADED VOLTAGE (LOADED VLITH) AND THE UNLOADED VOLTAGE (UNLOADED VLITH) DISPLAY AT THE POWER GRAPH MANAGEMENT TOOL SHOWS ABNORMAL BEHAVIOR. PUMP TRACE DOWNLOAD ANALYSIS CONFIRMED THE PUMP ALARMED PUMP ERROR 25, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND POWER LOSS ALARM. REPLACE BATTERY ALERT WAS FOUND ON: 04/11/2024 16:00:00.000. 04/11/2024 16:00:00.000. INSERT BATTERY ALARM WAS FOUND ON: 04/11/2024 16:07:12.000. 04/11/2024 16:07:22.000. 04/11/2024 16:07:41.000. REPLACE BATTERY NOW ALARM WAS FOUND ON: 04/11/2024 16:31:00.000. 04/11/2024 16:41:00.000. POWER LOSS ALARM WAS FOUND ON: 04/11/2024 17:21:49.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS FOUND ON: 04/11/2024 16:07:14.000. 04/11/2024 16:07:30.000. 04/11/2024 16:07:30.000. PUMP ERROR 25 ALARM WAS FOUND ON: 04/11/2024 22:00:00.000 TO 04/11/2024 22:10:00.000. 04/12/2024 02:10:00.000 TO 04/12/2024 22:00:00.000. 04/13/2024 02:00:00.000 TO 04/13/2024 22:10:00.000. 04/14/2024 02:00:00.000 TO 04/14/2024 22:10:00.000. 04/15/2024 06:55:18.000 TO 04/15/2024 22:00:25.000. 04/16/2024 02:00:00.000 TO 04/16/2024 22:00:20.000. POWER MANAGEMENT TOOL CONFIRMED PUMP ERROR 25 ALARM, UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND POWER LOSS ALARM WERE TRIGGERED WHEN THE BACKUP BATTERY LOADED VOLTAGE (LOADED VLITH) WAS LESS THAN 3.5V FOR 4 CONSECUTIVE HOURS DUE TO CONNECTOR RESISTANCE J6/PCB1. AFTER DISCONNECTING AND RECONNECTING THE INTERNAL BATTERY CONNECTOR ON J6/PCB 1, THE PUMP WAS MONITORED AND FUNCTIONED PROPERLY. PERFORMED VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. ¿ PLEASE SEE BELOW FOR PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 16-APR-2024 IN THE FORMATTED HISTORY FILE. LOSTSENSOR1ALERT (780) WAS FOUND ON: 04/13/2024 07:16:00.000 TO 04/13/2024 23:08:00.000. 04/14/2024 20:48:00.000 AND 04/14/2024 20:58:00.000. 04/16/2024 06:58:00.000 TO 04/16/2024 13:38:00.000. LOSTSENSOR2ALERT (781) WAS FOUND ON: 04/13/2024 07:42:00.000. 04/16/2024 07:28:00.000 TO 04/16/2024 12:03:00.000. 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 239 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO LOST SENSOR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY AND A SCRATCHED CASE. PUMP ERROR 25 ALARM, UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND POWER LOSS ALARM WERE CONFIRMED DUE TO CONNECTOR RESISTANCE J6/PCB1. 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. 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. 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 UNEXPECTED BATTERY POWER LOSS. THE CUSTOMER REPORTED NO ADVERSE EVENT. THE EVENT INVOLVED PRODUCT(S) MMT-1886. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND REVERT TO BACK UP PLAN AS PER HEALTH CARE PROVIDER INSTRUCTIONS. MMT-1886 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2134346 PUMP 1886 780G OUS BLE PUMP MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 HG4VVR6ZZ 000000763000384289

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Unknown