BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 17696388 · Received September 7, 2023

    Report

    Report Number
    2032227-2023-268335
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 17, 2023
    Report Date
    December 2, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439859
    PMA / PMN Number
    P150001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A MINOR SCRATCHED LCD WINDOW, A CRACKED BATTERY TUBE THREADS AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. PUMP WAS ALSO RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO VERIFY REPROGRAM ALARM, LOW BATTERY LIFE OR LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND 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. SUCCESSFULLY DOWNLOADED PUMP TRACES AND HISTORY FILE USING THUMP. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM TRIGGERED BY THREE CONSECUTIVE PUMP ERROR 40 ALARMS ON (B)(6) 2023 10:01:00.000 AND (B)(6) 202310:11:00.000. AS PER GLOBAL LOGIC ANALYSIS (ESF#(B)(4), PUMP ERROR 40 ALARMS (LINE NUMBER 525 FILE NUMBER 121), SUSPECTED ON SW. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 17-AUG-2023 IN THE FORMATTED HISTORY FILE.  LOSTSENSOR1ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 02:09:00.000. (B)(6) 2023 13:24:00.000. (B)(6) 202320:56:00.000. (B)(6) 2023 21:06:00.000. LOSTSENSOR2ALERT (781) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 202321:23:00.000. (B)(6) 2023 21:33:00.000. SENSOREXPIREDALERT (794) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 202320:13:37.000. (B)(6) 2023 20:23:00.000. UNABLE TO TEST FOR LOST SENSOR ALERT AND SENSOR EXPIRED ALERT DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. LOST SENSOR ALERT AND SENSOR EXPIRED ALERT WERE UNKNOWN. PUMP ERROR 63 ALARM (VARIABLEINFO = 15) (FILE NUMBER: 2017 LINE NUMBER: 147) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 11:17:09.000 PUMP ERROR 63 ALARM (VARIABLEINFO = 15) (FILE NUMBER: 2017 LINE NUMBER: 147) WAS CONFIRMED SUSPECTED ON HW. 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. THERE WAS NO POWER ERROR 25 ALARM, LOW BATTERY LIFE OR LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM, POWER LOSS ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE ON THE EVENT DATE. UNABLE TO TEST FOR REPROGRAM ALARM, LOW BATTERY LIFE OR LOW BATTERY ALERT AND FAILED BATTERY ALERT/BATTERY FAILED ALARM DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. REPROGRAM ALARM, LOW BATTERY LIFE OR LOW BATTERY ALERT AND FAILED BATTERY ALERT/BATTERY FAILED ALARM WERE UNKNOWN. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCBA 1 AND PCBA 2. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. ¿ TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. COSMETIC DAMAGE WAS CONFIRMED AT THE SCREEN AND BACK (NEAR THE BATTERY AREA) OF THE PUMP. UNABLE TO VERIFY REPROGRAM ALARM, LOW BATTERY LIFE OR LOW BATTERY ALERT, FAILED BATTERY ALERT/BATTERY FAILED ALARM AND PERFORM THE REQUIRED TESTING DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO THREE CONSECUTIVE PUMP ERROR 40 ALARMS. PUMP ERROR 40 ALARM, SUSPECTED ON SW. PUMP ERROR 63 ALARM (VARIABLEINFO = 15) (FILE NUMBER: 2017 LINE NUMBER: 147) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE, SUSPECTED ON HW. DURING VISUAL INSPECTION, CORROSION WAS FOUND ON THE PCBA 1 AND PCBA 2. PUMP EXPOSED TO MOISTURE WAS CONFIRMED. 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 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, 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 THE INSULIN PUMP HAD COSMETIC DAMAGE NEAR THE BATTERY AREA AND WAS EXPOSED TO MOISTURE. THE INSULIN PUMP HAD DIMINISHED BATTERY LIFE AND LOST SETTINGS AFTER THE BATTERY CHANGE. THE PUMP HAD REJECTED THE BATTERIES AND FOUND A SCRATCH ON THE SCREEN. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DISCONTINUED USING THE PUMP AND IT WILL BE RETURNED FOR PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170087 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 HG56734ZZ 000000763000439859

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female