BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 17264950 · Received July 6, 2023

    Report

    Report Number
    2032227-2023-232024
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 18, 2023
    Report Date
    August 23, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO BLANK DISPLAY NOTED. 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. UNABLE TO TEST FOR PUMP ERROR 23 AND UNEXPECTED BATTERY POWER LOSS ANOMALY DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORRODED FORCE SENSOR. MOISTURE DAMAGE WAS FOUND ON THE PCBA 1, PCBA 2 AND 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 ON 06/18/2023 18:07:03.000 AND ON 06/18/2023 18:17:00.000 DUE TO CORRODED FORCE SENSOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WIDOW, SCRATCHED DISPLAY WINDOW COVER, CRACKED BATTERY TUBE THREADS, CRACKED CASE BATTERY TUBE SIDE, FADED/SCRATCHED SERIAL NUMBER LABEL, KEYPAD OVERLAY TEXTURE DAMAGE, SCRATCHED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 18-JUN-2023 IN THE PUMP HISTORY FILE (PRIMARY SVN 000315899339). PUMP ERROR 35 - BROKENFORCESENSORERROR (35) WAS CONFIRMED IN THE PUMP HISTORY FILE. 06/18/2023 18:17:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BROKENFORCESENSORERROR (35). 06/18/2023 18:27:12.000 BATTERYREMOVED (55). 06/18/2023 18:27:12.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). PUMP ERROR 35 - BROKENFORCESENSORERROR (35) CONFIRMED. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 18-MAY-2023 IN THE PUMP HISTORY FILE (SVN 000315770142). 05/16/2023 01:25:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOSTSENSOR1ALERT (780). 05/16/2023 01:35:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOSTSENSOR1ALERT (780). 05/18/2023 00:02:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: CHANGEBATTERYFAULT (73). 05/18/2023 00:12:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: CHANGEBATTERYFAULT (73). 05/18/2023 00:33:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: OFFNOPOWER (11). 05/18/2023 00:44:03.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: POSTRESETRAMCRCALARM (23). 05/18/2023 00:44:46.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTOUTLIMIT (6). 05/18/2023 00:44:54.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTOUTLIMIT (6). THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. UNABLE TO TEST FOR LOST SENSOR ALARM, CHANGEBATTERYFAULT ALERT, OFFNOPOWER ALARM, PUMP ERROR 23 OR BATTERY OUT LIMIT ALARM DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. LOSTSENSOR1ALERT (780) UNKNOWN. CHANGEBATTERYFAULT (73) UNKNOWN. OFFNOPOWER (11) UNKNOWN. PUMP ERROR 23 UNKNOWN. BATTOUTLIMIT (6) UNKNOWN. 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 ALARM. PUMP ERROR 35 ALARM CONFIRMED DUE TO CORRODED FORCE SENSOR. BLANK DISPLAY NOT CONFIRMED. PUMP ERROR 23 UNKNOWN. UNEXPECTED BATTERY POWER LOSS UNKNOWN. 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.

    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED THE ERROR CODE OF A BROKEN FORCE SENSOR WAS DETECTED DURING SEATING OR REGULAR DELIVERY (PUMP ERROR 35) WHEN CHANGING THE RESERVOIR. TROUBLESHOOTING WAS PERFORMED AND EXPLAINED THE PUMP PERFORMED SAFETY CHECKS AND THE ERROR WAS FOUND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE AND REVERT TO THE BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973169 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 HG5ZEGUZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male