BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 17017834 · Received May 30, 2023

    Report

    Report Number
    2032227-2023-210963
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 9, 2023
    Report Date
    July 14, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000640095
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. THE PUMP WAS MONITORED FOR SEVERAL HOURS AND NO UNEXPECTED LOW BATTERY LIFE OR LOW BATTERY ALARM NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. 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 OR ALERTS WERE NOTED. NO POWER ERROR 25, LOW BATTERY LIFE OR LOW BATTERY ALERT AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE ON THE EVENT DATE. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/03/2023 11:03:11.000 05/03/2023 11:59:15.000 05/08/2023 10:07:39.000 05/08/2023 10:08:19.000 FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/03/2023 10:57:50.000, 05/03/2023 10:58:21.000, 05/03/2023 11:03:39.000, 05/03/2023 11:03:51.000 05/03/2023 11:13:00.000 05/08/2023 09:57:54.000, 05/08/2023 10:07:00.000, 05/08/2023 10:08:00.000, 05/08/2023 10:08:10.000 05/08/2023 10:18:00.000 POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/03/2023 17:11:06.000 05/08/2023 10:30:24.000 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 18-MAY-2023 AT 9:24:58 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF 03-MAY-2023 AND 08-MAY-2023. UNABLE TO CHECK POWER DATA FOR FAILED BATTERY ALERT/BATTERY FAILED ALARM AND POWER LOSS ALARM. NO FAILED BATTERY ALERT/BATTERY FAILED ALARM AND POWER LOSS ALARM NOTED DURING TESTING. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 09-MAY-2023 IN THE FORMATTED HISTORY FILE.  PUMP ERROR 43 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/03/2023 10:57:27.000 05/08/2023 09:57:29.000 PUMP ERROR 41 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 05/03/2023 10:57:27.000 05/08/2023 09:57:29.000 PUMP ERROR 43 ALARM AND PUMP ERROR 41 ALARM (FILE NUMBER: 121 121 LINE NUMBER: 589 713) WERE CONFIRMED, SUSPECTED ON HW. 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. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. LOW BATTERY LIFE OR LOW BATTERY ALERT WAS NOT CONFIRMED. HOWEVER, PUMP ERROR 43 ALARM AND PUMP ERROR 41 ALARM (FILE NUMBER: 121 121 LINE NUMBER: 589 713) WERE CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. 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 REPORTED RECEIVING A LOW BATTERY ALARM OR SHORT BATTERY LIFE. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER DID NOT RECEIVED REPLACE BATTERY NOW ALARM OR POWER ERROR DETECTED. ADVISED CUSTOMER TO REPLACE THE BATTERY AND THE NEW BATTERY WILL RESOLVE THE ISSUE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND THE PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553049 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 NG3242453H 000000763000640095

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female