BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 15742223 · Received November 7, 2022

    Report

    Report Number
    2032227-2022-356311
    Event Type
    Injury
    Date Received
    November 7, 2022
    Date of Event
    September 14, 2022
    Report Date
    January 16, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, POSSIBLE UNDER DELIVERY ANOMALY AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6)2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, POSSIBLE UNDER DELIVERY ANOMALY AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, STUCK BUTTON ALARM AND NO DELIVERY ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SBN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, STUCK BUTTON ALARM AND NO DELIVERY ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6) 2022. ON SVN (B)(4) THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BG'S/DKA, PUMP NOT DELIVERING INSULIN, AND STUCK BUTTON ALARM ON (B)(6)2022. THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT AT 0.0868 INCHES. NO UNDER DELIVERY ANOMALY NOTED. NO BOLUS ANOMALY OR BASAL ANOMALY NOTED. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. ALL BUTTONS FUNCTION PROPERLY DURING TESTING. NO UNRESPONSIVE BUTTONS NOTED. NO STUCK BUTON ALARM/BUTTON ERROR ALARM NOTED DURING TESTING. NO DAMAGE NOTED ON THE KEYPAD TRACES. THE PUMP PASSED THE KEYPAD VOLTAGE TEST. STUCK BUTON ALARM CONFIRMED IN THE PUMP HISTORY FILE, PROBLEM ISOLATED TO THE KEYPAD ASSEMBLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, SCRATCHED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. PLEASE SEE BELOW FOR THE BOLUSES LISTED ON THE EVENT DATES (B)(6) 2022 IN THE PUMP HISTORY FILE. (B)(6) 2022 06:12:36.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 1.6. BOLUS AMOUNT DELIVERED = 1.6. (B)(6) 2022 10:34:48.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = MANUAL BOLUS. NORMAL BOLUS AMOUNT PROGRAMMED = 1.4. BOLUS AMOUNT DELIVERED = 1.4. (B)(6) 2022 18:37:22.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 7.3. BOLUS AMOUNT DELIVERED = 7.3. (B)(6) 2022 23:06:40.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 4.1. BOLUS AMOUNT DELIVERED = 4.1. PLEASE SEE BELOW FOR THE ALARMS LISTED ON THE EVENT DATES (B)(6) 2022 IN THE PUMP HISTORY FILE. (B)(6) 2022 06:11:12.000 ALARM ALERT NOTIFICATION. SYSTEM TIME = (B)(6) 2022 06:11:12.000 FAULTNUMBER = BOLUS NOT DELIVERED ALERT(100). (B)(6) 2022 20:54:29.000 ALARM ALERT NOTIFICATION FAULT NUMBER = STUCK KEY ALARM (61). (B)(6) 2022 03:13:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = LOW RESERVOIR ALERT(105) (B)(6) 2022 13:30:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = RESERVOIR ESTIMATE 0 ALERT(113). (B)(6) 2022 21:26:47.000 ALARM ALERT NOTIFICATION FAULT NUMBER = STUCK KEY ALARM (61). THERE WERE NO AUTO SUSPEND ALARM OR USER SUSPEND ALERT NOTED ON THE EVENT DATES (B)(6) 2022 IN THE PUMP HISTORY FILE. THERE WAS NO STUCK BUTTON ALARM LISTED ON 2022. THERE WERE STUCK BUTTON ALARMS LISTED IN THE PUMP HISTORY FILE ON THE DATES BELOW. (B)(6) 2022 20:54:29.000 ALARM ALERT NOTIFICATION FAULT NUMBER = STUCK KEY ALARM (61). (B)(6) 2022 21:02:54.000 ALARM ALERT NOTIFICATION FAULT NUMBER = STUCK KEY ALARM (61). (B)(6) 2022 17:51:47.000 ALARM ALERT NOTIFICATION FAULT NUMBER = STUCK KEY ALARM (61). THERE WERE NO "NO DELIVERY ALARM" LISTED ON THE EVENT DATES (B)(6) 2022 IN THE PUMP HISTORY FILE. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE. ON THE ELECTRONIC ASSEMBLY, MOTOR, FORCE SENSOR OR KEYPAD FLEX CABLE. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BG'S/DKA. POSSIBLE UNDER DELIVERY ANOMALY WAS NOT CONFIRMED. STUCK BUTTON/KEY ALARM CONFIRMED. NO DELIVERY ALARM/INSULIN FLOW BLOCK ALARM NOT 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

    THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT AT 0.0868 INCHES. NO UNDER DELIVERY ANOMALY NOTED. NO BOLUS ANOMALY OR BASAL ANOMALY NOTED. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. ALL BUTTONS FUNCTION PROPERLY DURING TESTING. NO UNRESPONSIVE BUTTONS NOTED. NO STUCK BUTON ALARM/BUTTON ERROR ALARM NOTED DURING TESTING. NO DAMAGE NOTED ON THE KEYPAD TRACES. THE PUMP PASSED THE KEYPAD VOLTAGE TEST. STUCK BUTON ALARM CONFIRMED IN THE PUMP HISTORY FILE, PROBLEM ISOLATED TO THE KEYPAD ASSEMBLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, SCRATCHED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. PLEASE SEE BELOW FOR THE BOLUSES LISTED ON THE EVENT DATES 09/14/2022 AND 09/19/2022 IN THE PUMP HISTORY FILE. (B)(6) 2022 06:12:36.000 NORMALBOLUSDELIVERED, BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 1.6 BOLUSAMOUNTDELIVERED = 1.6 (B)(6) 2022 10:34:48.000 NORMALBOLUSDELIVERED, BOLUSPROGRAMMINGMETHOD = MANUAL BOLUS NORMALBOLUSAMOUNTPROGRAMMED = 1.4 BOLUSAMOUNTDELIVERED = 1.4 (B)(6) 2022 18:37:22.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 7.3 BOLUSAMOUNTDELIVERED = 7.3 (B)(6) 2022 23:06:40.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 4.1 BOLUSAMOUNTDELIVERED = 4.1 PLEASE SEE BELOW FOR THE ALARMS LISTED ON THE EVENT DATES 09/14/2022 AND 09/19/2022 IN THE PUMP HISTORY FILE. (B)(6) 2022 06:11:12.000 ALARMALERTNOTIFICATION SYSTEMTIME = (B)(6)2022 06:11:12.000 FAULTNUMBER = BOLUS NOT DELIVERED ALERT(100) (B)(6)2022 20:54:29.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK KEY ALARM (61) (B)(6)2022 03:13:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW RESERVOIR ALERT(105) (B)(6)2022 13:30:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = RESERVOIR ESTIMATE 0 ALERT(113) (B)(6)2022 21:26:47.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK KEY ALARM (61) THERE WERE NO AUTO SUSPEND ALARM OR USER SUSPEND ALERT NOTED ON THE EVENT DATES (B)(6)2022 AND (B)(6)2022 IN THE PUMP HISTORY FILE. THERE WAS NO STUCK BUTTON ALARM LISTED ON (B)(6)2022, (B)(6)2022, (B)(6)2022, (B)(6)2022, (B)(6)2022, (B)(6)2022, (B)(6)2022, (B)(6)2022, (B)(6)2022, (B)(6)2022, (B)(6)2022, (B)(6)2022, (B)(6)2022, (B)(6)2022 OR (B)(6)2022. THERE WERE STUCK BUTTON ALARMS LISTED IN THE PUMP HISTORY FILE ON THE DATES BELOW. (B)(6)2022 20:54:29.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK KEY ALARM (61) .(B)(6)2022 21:02:54.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK KEY ALARM (61). (B)(6)2022 17:51:47.000 ALARMALERTNOTIFICATION FAULTNUMBER = STUCK KEY ALARM (61). THERE WERE NO "NO DELIVERY ALARM" LISTED ON THE EVENT DATES (B)(6) 2022 AND (B)(6) 2022 IN THE PUMP HISTORY FILE. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND¿NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE¿ON THE ELECTRONIC ASSEMBLY, MOTOR, FORCE SENSOR OR KEYPAD FLEX CABLE. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BG'S/DKA. POSSIBLE UNDER DELIVERY ANOMALY WAS NOT CONFIRMED. STUCK BUTTON/KEY ALARM CONFIRMED. NO DELIVERY ALARM/INSULIN FLOW BLOCK ALARM NOT 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. INFORMATION HAS BEEN CORRECTED WHICH WAS NOT CORRECT IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 WITH THIS REPORT. THE INITIAL REPORT HAD AN INCORRECT AWARE DATE. THE CORRECT AWARE DATE IS 13-OCT-2022.

    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. 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. THE INFORMATION THAT PROVIDED WITH THE INITIAL REPORT WAS INCORRECT. THE CORRECT INFORMATION HAS BEEN INCLUDED WITH THIS REPORT IN B5 SECTION.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PUMP WAS NOT DELIVERING THE INSULIN. THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER ALSO HAD STUCK BUTTON WHICH LED TO HIGH BLOOD GLUCOSE EVENT. THE BLOOD GLUCOSE VALUE AT THE TIME OF EVENT WAS 482 MG/DL. THE CUSTOMER REPORTED NAUSEA AS A SYMPTOM OF HIGH BLOOD GLUCOSE EVENT. THE AUTO MODE FEATURE WAS NOT ACTIVATED AT THE TIME OF HIGH BLOOD GLUCOSE EVENT. TROUBLESHOOTING WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HYPERGLYCEMIA ON (B)(6) 2022 DUE TO A STUCK BUTTON ALARM. THE BLOOD GLUCOSE WAS 482 MG/DL. THE CUSTOMER ALSO REPORTED A HOSPITALIZATION THAT OCCURRED ON (B)(6) 2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208399 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG5D0QV 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Hospitalization FRN-MMT-332A-RSVR, MMT-945A-UNOMED SET