BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 17365348 · Received July 20, 2023

    Report

    Report Number
    2032227-2023-239927
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    July 2, 2023
    Report Date
    September 4, 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
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORRODED PCBA 1, PCBA 2 AND FORCE SENSOR. MOISTURE DAMAGE WAS FOUND ON THE 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 (B)(6) 2023 10:03:00.000 AND ON (B)(6) 2023 10:13:00.000 DUE TO CORRODED FORCE SENSOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, 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 ERRORS/ALARMS NOTED 2 DAYS PRIOR TO THE EVENT DATE 02-JUL-2023 IN THE PUMP HISTORY FILE. ON (B)(6) 2023 11:59:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOSTSENSOR1ALERT (780) ON (B)(6) 2023 12:15:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: LOSTSENSOR2ALERT (781) ON (B)(6) 2023 10:03:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BROKENFORCESENSORERROR (35) ON (B)(6) 2023 10:12:58.000 BATTERYREMOVED (55) ON (B)(6) 2023 10:12:58.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) ON (B)(6) 2023 10:12:58.000 BATTERYINSERTED (44) ON (B)(6) 2023 10:12:58.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) ON (B)(6) 2023 10:13:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BROKENFORCESENSORERROR (35) ON (B)(6) 2023 10:25:55.000 BATTERYREMOVED (55) ON (B)(6) 2023 10:25:55.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) ON (B)(6) 2023 10:26:32.000 BATTERYINSERTED (44) ON (B)(6) 2023 10:29:26.000 BATTERYREMOVED (55) ON (B)(6) 2023 10:29:26.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) ON (B)(6) 2023 10:29:26.000 BATTERYINSERTED (44) ON (B)(6) 2023 10:29:26.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) ON (B)(6) 2023 10:29:29.000 BATTERYREMOVED (55) ON (B)(6) 2023 10:29:29.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) UNABLE TO TEST FOR LOST SENSOR ALARM AND FAILED BATTERY TEST ALARM DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. HOWEVER, THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. PUMP ERROR 35 FATAL ALARM CONFIRMED IN THE HISTORY FILE. LOSTSENSOR1ALERT (780) UNKNOWN. PUMP ERROR 35 - BROKENFORCESENSORERROR (35) CONFIRMED. FAILEDBATTTEST (58) 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. E/A ALARM UNSPECIFIED CONFIRMED (FOUND PUMP ERROR 35 IN THE PUMP HISTORY FILE). EXPOSURE TO MOISTURE 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. 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 A CRITICAL PUMP ERROR. THE CUSTOMER ALSO REPORTED THAT THE PUMP GOT WET. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE INSULIN PUMP PERFORMED SAFETY CHECKS AND THE ERROR WAS FOUND. IT WAS FOUND THAT THE PUMP HAD OTHER CRITICAL PUMP ERROR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39084 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 HG68THWZZ 000000763000439859

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male