MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2023-322718
- Event Type
- Injury
- Date Received
- December 27, 2023
- Date of Event
- December 1, 2023
- Report Date
- May 20, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000545604
- PMA / PMN Number
- P150001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- 003
Narratives
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 0.0874 INCHES. POSSIBLE OVER DELIVERY ANOMALY NOT CONFIRMED. BOLUS ANOMALY NOT CONFIRMED. PER (B)(6) ¿ R&D ENGINEER: ON (B)(6) 2023, THE USER PROGRAMMED ONE BOLUS USING BOLUS WIZARD: ON (B)(6) 2023 10:10:25.000 BOLUS WIZARD ESTIMATE (61) EVENT TYPE : 61, SOURCE ID : 0, HISTORY RECORD LENGTH: 53, SYSTEM TIME: (B)(6) 2023 10:10:25.000, BG UNITS: MG PER DL (0), CARB UNITS: GRAMS (0), BG VALUE: 118, FOOD INPUT: 100, CURRENT INSULIN SENSITIVITY FACTOR: 15, CURRENT CARB RATIO: 40, CURRENT LOW BG TARGET RANGE: 100, CURRENT HIGH BG TARGET RANGE: 120, CORRECTION ESTIMATE: 0, FOOD ESTIMATE: 250000, ACTIVE INSULIN: 0, ACTIVE INSULIN ADJUSTMENT: 0, BOLUS WIZARD ESTIMATE: 250000, BOLUS PROGRAMMING STEP: 0.1U (2), ESTIMATE MODIFIED BY USER FLAG: BOLUS WIZARD ESTIMATE WAS NOT MODIFIED BY THE USER (0) FINAL ESTIMATE: 250000, (B)(6) 2023 10:10:25.000 NORMAL BOLUS PROGRAMMED (21), EVENT TYPE : 21 SOURCE ID : 0 HISTORY RECORD LENGTH : 22 SYSTEM TIME : (B)(6) 2023 10:10:25.000; BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1); BOLUS NUMBER: 47; PRESET BOLUS NUMBER: NONPRESET (0); NORMAL BOLUS AMOUNT PROGRAMMED: 250000 (25 U); ACTIVE INSULIN: 0 (0 U); 25U BOLUS WAS SUCCESSFULLY DELIVERED 2 MINUTES LATER. (B)(6) 2023 10:27:07.000 NORMAL BOLUS DELIVERED (220); EVENT TYPE: 220; SOURCE ID : 0; HISTORY RECORD LENGTH : 26; SYSTEM TIME : (B)(6) 2023 10:27:07.000; BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1); BOLUS NUMBER: 47; PRESET BOLUS NUMBER: NONPRESET (0); NORMAL BOLUS AMOUNT PROGRAMMED: 250000 (25 U); BOLUS AMOUNT DELIVERED: 250000 (25 U); ACTIVE INSULIN AT PROGRAMING TIME: 0 (0 U); AND FROM DIAGNOSTIC TRACES THAT RECORDED EVERY PUMP STROKE, : SUM((B)(6) :(B)(6) ):2000*0.0125: 25U. ALSO, AS PER DAILY TOTALS: (B)(6) 2023 00:00:00.000 DAILYTOTALSG670 (63); EVENT TYPE : 63; SOURCE ID : 0; HISTORY RECORD LENGTH : 114; SYSTEM TIME : (B)(6) 2023 00:00:00.000; DAILY TOTAL COLLECTION START TIME: (B)(6) 2023 00:00:00.000; COVERED DURATION: 1440 MIN; NUMBER OF METER BGS: 2; AVERAGE METER BG: 126 MG/DL; LOW METER BG: 118 MG/DL; HIGH METER BG: 133 MG/DL; BG STANDARD DEVIATION: 7 MG/DL; DAILY TOTAL OF ALL INSULIN DELIVERED: 789250 (78.925 U); DAILY TOTAL OF BASAL INSULIN DELIVERED: 539250 (53.925 U); PERCENTAGE OF DAILY TOTAL DELIVERED AS BASAL INSULIN: 68; DAILY TOTAL OF BOLUS INSULIN DELIVERED: 250000 (25 U); PERCENTAGE OF DAILY TOTAL DELIVERED AS BOLUS INSULIN: 32; TOTAL DAILY FOOD INPUT: 100 GRAMS; TOTAL OF BOLUS WIZARD INSULIN DELIVERED AS FOOD ONLY BOLUS: 250000 (25 U); TOTAL OF BOLUS WIZARD INSULIN DELIVERED AS CORRECTION ONLY BOLUS: 0 (0 U); CONCLUSION: PUMP BEHAVED AS EXPECTED: IT HAS ACCURATELY DELIVERED PROGRAMMED BY USER 25U BOLUS. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW FOR THE BOLUS LISTED ON THE EVENT DATE (B)(6) 2023 IN THE PUMP HISTORY FILE. (B)(6) 2023 10:27:07.000 NORMAL BOLUS DELIVERED (220); BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1); NORMAL BOLUS AMOUNT PROGRAMMED: 250000 (25 U); BOLUS AMOUNT DELIVERED: 250000 (25 U); PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE (B)(6) 2023 IN THE PUMP HISTORY FILE. (B)(6) 2023 00:00:00.000 DAILYTOTALSG670 (63); DAILY TOTAL COLLECTION START TIME: (B)(6) 2023 00:00:00.000; DAILY TOTAL OF ALL INSULIN DELIVERED: 789250 (78.925 U); DAILYTOTALOFBASALINSULINDELIVERED: 539250 (53.925 U); DAILY TOTAL OF BOLUS INSULIN DELIVERED: 250000 (25 U); THERE WERE NO AUTOSUSPEND (12) ALARM NOTED ON THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE USER SUSPENDED (2) ALARMS NOTED ON THE EVENT DATE (B)(6) 2023 IN THE PUMP HISTORY FILE. (B)(6) 2023 09:31:48.000 INSULINDELIVERYSTOPPED (30); REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2). (B)(6) 2023 12:24:09.000 INSULINDELIVERYSTOPPED (30); REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2). (B)(6) 2023 23:14:10.000 INSULINDELIVERYSTOPPED (30); REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2). THERE WERE NO UNEXPECTED PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6) 2023 IN THE PUMP HISTORY FILE. (B)(6) 2023 21:12:26.000 BATTERY REMOVED (55); (B)(6) 2023 21:12:26.000 ALARM ALERT NOTIFICATION (40); FAULTNUMBER: BATTERYREMOVED (84); (B)(6) 2023 21:12:46.000 BATTERYINSERTED (44). THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED LOW BGS. POSSIBLE OVER DELIVERY ANOMALY NOT CONFIRMED. BOLUS ANOMALY NOT CONFIRMED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
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 B2 AND B5 WITH THIS REPORT.
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 0.0874 INCHES. POSSIBLE OVER DELIVERY ANOMALY NOT CONFIRMED. BOLUS ANOMALY NOT CONFIRMED. PER (B)(6) ¿ R&D ENGINEER ON (B)(6) 2023, THE USER PROGRAMMED ONE BOLUS USING BOLUS WIZARD: (B)(6) 2023 10:10:25.000 BOLUSWIZARDESTIMATE (61) EVENTTYPE = 61 SOURCEID = 0 HISTORYRECORDLENGTH = 53 SYSTEMTIME = 12/01/2023 10:10:25.000 BGUNITS: MGPERDL (0) CARBUNITS: GRAMS (0) BGVALUE: 118 FOODINPUT: 100 CURRENTINSULINSENSITIVITYFACTOR: 15 CURRENTCARBRATIO: 40 CURRENTLOWBGTARGETRANGE: 100 CURRENTHIGHBGTARGETRANGE: 120 CORRECTIONESTIMATE: 0 FOODESTIMATE: 250000 ACTIVEINSULIN: 0 ACTIVEINSULINADJUSTMENT: 0 BOLUSWIZARDESTIMATE: 250000 BOLUSPROGRAMMINGSTEP: 0.1U (2) ESTIMATEMODIFIEDBYUSERFLAG: BOLUSWIZARDESTIMATEWASNOTMODIFIEDBYTHEUSER (0) FINALESTIMATE: 250000 (B)(6) 2023 10:10:25.000 NORMALBOLUSPROGRAMMED (21) EVENTTYPE = 21 SOURCEID = 0 HISTORYRECORDLENGTH = 22 SYSTEMTIME = (B)(6) 2023 10:10:25.000 BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) BOLUSNUMBER: 47 PRESETBOLUSNUMBER: NONPRESET (0) NORMALBOLUSAMOUNTPROGRAMMED: 250000 (25 U) ACTIVEINSULIN: 0 (0 U) 25U BOLUS WAS SUCCESSFULLY DELIVERED 2 MINUTES LATER. (B)(6) 2023 10:27:07.000 NORMALBOLUSDELIVERED (220) EVENTTYPE = 220 SOURCEID = 0 HISTORYRECORDLENGTH = 26 SYSTEMTIME = (B)(6) 2023 10:27:07.000 BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) BOLUSNUMBER: 47 PRESETBOLUSNUMBER: NONPRESET (0) NORMALBOLUSAMOUNTPROGRAMMED: 250000 (25 U) BOLUSAMOUNTDELIVERED: 250000 (25 U) ACTIVEINSULINATPROGRAMINGTIME: 0 (0 U) AND FROM DIAGNOSTIC TRACES THAT RECORDED EVERY PUMP STROKE, =SUM(AJ31206:AJ31740)=2000*0.0125=25U. ALSO, AS PER DAILYTOTALS: (B)(6) 2023 00:00:00.000 DAILYTOTALSG670 (63) EVENTTYPE = 63 SOURCEID = 0 HISTORYRECORDLENGTH = 114 SYSTEMTIME = (B)(6) 2023 00:00:00.000 DAILYTOTALCOLLECTIONSTARTTIME: (B)(6) 2023 00:00:00.000 COVEREDDURATION: 1440 MIN NUMBEROFMETERBGS: 2 AVERAGEMETERBG: 126 MG/DL LOWMETERBG: 118 MG/DL HIGHMETERBG: 133 MG/DL BGSTANDARDDEVIATION: 7 MG/DL DAILYTOTALOFALLINSULINDELIVERED: 789250 (78.925 U) DAILYTOTALOFBASALINSULINDELIVERED: 539250 (53.925 U) PERCENTAGEOFDAILYTOTALDELIVEREDASBASALINSULIN: 68 DAILYTOTALOFBOLUSINSULINDELIVERED: 250000 (25 U) PERCENTAGEOFDAILYTOTALDELIVEREDASBOLUSINSULIN: 32 TOTALDAILYFOODINPUT: 100 GRAMS TOTALOFBOLUSWIZARDINSULINDELIVEREDASFOODONLYBOLUS: 250000 (25 U) TOTALOFBOLUSWIZARDINSULINDELIVEREDASCORRECTIONONLYBOLUS: 0 (0 U) CONCLUSION: PUMP BEHAVED AS EXPECTED: IT HAS ACCURATELY DELIVERED PROGRAMMED BY USER 25U BOLUS. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW FOR THE BOLUS LISTED ON THE EVENT DATE 01-DEC-2023 IN THE PUMP HISTORY FILE. (B)(6) 2023 10:27:07.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 250000 (25 U) BOLUSAMOUNTDELIVERED: 250000 (25 U) PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE 01-DEC-2023 IN THE PUMP HISTORY FILE. (B)(6) 2023 00:00:00.000 DAILYTOTALSG670 (63) DAILYTOTALCOLLECTIONSTARTTIME: (B)(6) 2023 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 789250 (78.925 U) DAILYTOTALOFBASALINSULINDELIVERED: 539250 (53.925 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 250000 (25 U) THERE WERE NO AUTOSUSPEND (12) ALARM NOTED ON THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE USERSUSPENDED (2) ALARMS NOTED ON THE EVENT DATE 01-DEC-2023 IN THE PUMP HISTORY FILE. (B)(6) 2023 09:31:48.000 INSULINDELIVERYSTOPPED (30) REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2) (B)(6) 2023 12:24:09.000 INSULINDELIVERYSTOPPED (30) REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2) (B)(6) 2023 23:14:10.000 INSULINDELIVERYSTOPPED (30) REASONFOINSULINDELIVERYSUSPENSION: USERSUSPENDED (2) THERE WERE NO UNEXPECTED PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 01-DEC-2023 IN THE PUMP HISTORY FILE. (B)(6) 2023 21:12:26.000 BATTERYREMOVED (55) (B)(6) 2023 21:12:26.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2023 21:12:46.000 BATTERYINSERTED (44) THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED LOW BGS. POSSIBLE OVER DELIVERY ANOMALY NOT CONFIRMED. BOLUS ANOMALY 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.
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.
CUSTOMER REPORTED HAVING A LOW BLOOD GLUCOSE ON (B)(6) 2023. CUSTOMER TREATED THE LOW WITH FOOD AND GLUCOSE TABLETS. CUSTOMER WENT TO THE EMERGENCY ROOM. CUSTOMER WAS NOT TREATED WITH INSULIN DRIP BUT WITH INTRAVENOUS INFUSION. CUSTOMER ALLEGED THE PUMP OVER DELIVERED INSULIN. PUMP WAS USED AT THE TIME OF THE LOW EVENT.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 62 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER HAS TREATED THE LOW BLOOD GLUCOSE EVENT WITH GLUCOSE, GLUCOSE TABLETS, INTRAVENOUS DRIP AND EMERGENCY MEDICAL SERVICES. THE CUSTOMER REPORTED SHAKING AND SWEATING AS SYMPTOMS. IT WAS FOUND THAT THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS OF THE REPORTED EVENT AND THE AUTO-MODE FEATURE WAS NOT ACTIVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1609962 | 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 | NG3222688H | 000000763000545604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Male | Required Intervention| O | FRN-MMT-332A-RSVR, UNOMED INF SET |