PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
Report
- Report Number
- 2032227-2021-141001
- Event Type
- Death
- Date Received
- April 30, 2021
- Date of Event
- April 25, 2021
- Report Date
- February 9, 2022
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
DEVICE RECEIVED WITH A DEPLETED DURACELL ALKALINE BATTERY INSTALLED AT 1.039 VOLTS. DEVICE 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 DELIVERY ACCURACY TEST AT 0.0875 INCHES. THE TEST RESERVOIR VOLUME MATCHES THE UNITS LEFT IN THE PUMP STATUS SCREEN. NO UNITS LEFT ANOMALY NOTED. NO UNEXPECTED EMPTY RESERVOIR ALARM, UNEXPECTED AUDIO ALARM OR UNEXPECTED E/A ALARM NOTED DURING TESTING. THE LOW RESERVOIR REMINDER WAS SET TO 25.0 UNITS. THE LOW RESERVOIR REMINDER FUNCTIONS PROPERLY. DEVICE UPLOADED PROPERLY USING CARELINK. DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, SCRATCHED SERIAL NUMBER LABEL AND A PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. DATA ANALYSIS: (B)(6) 2021 DAILY TOTAL OF ALLINSULIN DELIVERED = 54.45. (B)(6) 2021 DAILY TOTAL OF ALLINSULIN DELIVERED = 33.3. (B)(6) 2021 DAILY TOTAL OF ALLINSULIN DELIVERED = 44.75. (B)(6) 2021 DAILY TOTAL OF ALLINSULIN DELIVERED = 45.1. (B)(6) 2021 DAILY TOTAL OF ALLINSULIN DELIVERED = 70.175. (B)(6) 2021 DAILY TOTAL OF ALLINSULIN DELIVERED = 7.95. (B)(6) 2021 DAILY TOTAL OF ALLINSULIN DELIVERED = 0. THE FOLLOWING TESTING WAS ALSO COMPLETED: 1. RECORD THE VALUE OF THE USER CONFIGURABLE ¿LOW INSULIN REMINDER¿ FROM THE (B)(6) PUMP USER INTERFACE SETTING. DEFAULT IS 20.0U. 2. IF POSSIBLE, RECORD EVENTS IN ¿HISTORY¿ LOGS WITHIN THE UI. 3. USING THE (B)(6) PUMP, SETUP EQUIPMENT PER STANDARD 1UPH TRUMPET CURVE PROTOCOL ((B)(4)) WITH THE FOLLOWING DEVIATIONS: A. FILL 1.8ML OR 3.0ML RESERVOIR WITH ~1.25ML OF ROOM TEMPERATURE HUMALOG INSTEAD OF DILUENT. 4. INSTALL (B)(6) ONTO SCALE SETUP AND BEGIN DAQ WITH PUMP DELIVERING AT 1UPH 5. ALLOW (B)(6) TO DELIVER FOR AT LEAST 2 DAYS A. DELIVER >= 48U B. THIS ALLOWS US TO OBSERVE DELIVERY STARTING AT ~125U REMAINING AND THEN ENDING AT ~75U REMAINING 6. STOP DELIVERY. STOP DAQ. REMOVE PUMP FROM DVA EQUIPMENT. 7. REVIEW STATUS OF PUMP UI: RESULTS: NO ALARMS OR ALERTS NOTED IN UI AS PUMP DELIVERED FROM AN INITIAL AMOUNT OF 125.9U TO A FINAL AMOUNT OF 56.9U AT A CONSTANT BASAL RATE OF 1.0UPH. A. INSPECT UI FOR ANY ALARMS/ALERTS B. RECORD REMAINING INSULIN 8. REVIEW MASS VS. TIME DATA LOG FOR ANY ABNORMALITIES. RESULTS: THE MASS VS. TIME CHART SHOWS NOTHING CONCERNING. THERE WAS A BUBBLE RELEASE ABOUT A DAY AND HALF INTO THE BASAL DELIVERY WITH NO ADVERSE, UNEXPECTED ISSUES. ADDITIONALLY, IT APPEARS THAT A POWER CABLE CAME LOOSE DURING THE TEST AND SWUNG LIKE A PENDULUM, CREATING A PERIOD OF MECHANICAL NOISE THAT WAS PICKED UP BY THE SCALE FOR ABOUT FOUR MINUTES. THIS NOISE DID NOT AFFECT THE OVERALL ACCURACY OF THE DELIVERY RECORDED BY THE SCALE. 9. SUMMARIZE FINDINGS AND DISTRIBUTE TO THIS TEAM. RESULTS: AFTER A REVIEW OF THE DAILY HISTORY AND ALARM HISTORY GOING BACK TO (B)(6), 2021, THERE APPEARS TO BE NO INDICATION OF ANY UNUSUAL ACTIVITY, ALARMS OR ALERTS. THE PUMP MET MDT ACCURACY REQUIREMENTS PER 60601-2-24 VIA AN INFORMAL TEST. INSPECTION OF DELIVERY OVER A THREE DAY PERIOD SHOWS NO UNUSUAL DELIVERY PATTERNS. DEVICE PASSED FUNCTIONAL TESTING AND ADDITIONAL TESTING NOTED ABOVE. NOTE: (B)(6) SPOKE WITH CUSTOMERS MOTHER (B)(6) ON TUESDAY, (B)(6) 2021, 2021 AT ~12PM PST PER (B)(6) REQUEST. (B)(6) REQUESTED DESTRUCTIVE TESTING TO PERFORM AN INTERNAL VISUAL INSPECTION OF THE COMPONENTS. THE RESULTS OF THE INSPECTION ARE NOTED BELOW: DEVICE WAS CUT OPEN AND A VISUAL INSPECTION WAS PERFORMED. NO DAMAGE NOTED ON THE ELECTRONIC ASSEMBLY, MOTOR, FORCE SENSOR OR KEYPAD FLEX. HOWEVER, THERE WAS CORROSION NOTED AT THE END OF THE BATTERY TUBE UNDERNEATH THE POWER/VIBRATOR BOARD. FURTHER INSPECTION WITH A MICROSCOPE FOUND CORROSION NEAR THE BATTERY TUBE SPRING. 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.
INSULIN PUMP RECEIVED WITH A DEPLETED DURACELL ALKALINE BATTERY INSTALLED AT 1.039 VOLTS. DEVICE 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 DELIVERY ACCURACY TEST AT 0.0875 INCHES. THE TEST RESERVOIR VOLUME MATCHES THE UNITS LEFT IN THE INSULIN PUMP STATUS SCREEN. NO UNITS LEFT ANOMALY NOTED. NO UNEXPECTED EMPTY RESERVOIR ALARM, UNEXPECTED AUDIO ALARM OR UNEXPECTED E/A ALARM NOTED DURING TESTING. THE LOW RESERVOIR REMINDER WAS SET TO 25.0 UNITS. THE LOW RESERVOIR REMINDER FUNCTIONS PROPERLY. DEVICE UPLOADED PROPERLY USING CARELINK. DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, SCRATCHED SERIAL NUMBER LABEL AND A PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. DATA ANALYSIS: 04/19/2021 DAILY TOTAL OF ALL INSULIN DELIVERED= 54.45, 04/20/2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 33.3 04/21/2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 44.75, 04/22/2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 45.1 04/23/2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 70.175 ,04/24/2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 7.95 04/25/2021 DAILY TOTAL OF ALL INSULIN DELIVERED = 0 THE FOLLOWING TESTING WAS ALSO COMPLETED: 1. RECORD THE VALUE OF THE USER CONFIGURABLE ¿LOW INSULIN REMINDER¿ FROM THE NG2360675H INSULIN PUMP USER INTERFACE SETTING. DEFAULT IS 20.0UNITS. 2. IF POSSIBLE, RECORD EVENTS IN ¿HISTORY¿ LOGS WITHIN THE UI. 3. USING THE NG2360675H INSULIN PUMP, SETUP EQUIPMENT PER STANDARD 1UPH TRUMPET CURVE PROTOCOL (10826238DOC) WITH THE FOLLOWING DEVIATIONS: A. FILL 1.8ML OR 3.0ML RESERVOIR WITH ~1.25ML OF ROOM TEMPERATURE HUMALOG INSTEAD OF DILUENT. 4. INSTALL NG2360675H ONTO SCALE SETUP AND BEGIN DAQ WITH PUMP DELIVERING AT 1UPH 5. ALLOW NG2360675H TO DELIVER FOR AT LEAST 2 DAYS A. DELIVER >= 48 UNITS B. THIS ALLOWS US TO OBSERVE DELIVERY STARTING AT ~125UNITS REMAINING AND THEN ENDING AT ~75UNITS REMAINING 6. STOP DELIVERY. STOP DAQ. REMOVE PUMP FROM DVA EQUIPMENT. 7. REVIEW STATUS OF INSULIN PUMP UI: RESULTS: NO ALARMS OR ALERTS NOTED IN UI AS INSULIN PUMP DELIVERED FROM AN INITIAL AMOUNT OF 125.9UNITS TO A FINAL AMOUNT OF 56.9UNITS AT A CONSTANT BASAL RATE OF 1.0UPH. A. INSPECT UI FOR ANY ALARMS/ALERTS B. RECORD REMAINING INSULIN 8. REVIEW MASS VS. TIME DATA LOG FOR ANY ABNORMALITIES. RESULTS: THE MASS VS. TIME CHART SHOWS NOTHING CONCERNING. THERE WAS A BUBBLE RELEASE ABOUT A DAY AND HALF INTO THE BASAL DELIVERY WITH NO ADVERSE, UNEXPECTED ISSUES. ADDITIONALLY, IT APPEARS THAT A POWER CABLE CAME LOOSE DURING THE TEST AND SWUNG LIKE A PENDULUM, CREATING A PERIOD OF MECHANICAL NOISE THAT WAS PICKED UP BY THE SCALE FOR ABOUT FOUR MINUTES. THIS NOISE DID NOT AFFECT THE OVERALL ACCURACY OF THE DELIVERY RECORDED BY THE SCALE. 9. SUMMARIZE FINDINGS AND DISTRIBUTE TO THIS TEAM. RESULTS: AFTER A REVIEW OF THE DAILY HISTORY AND ALARM HISTORY GOING BACK TO MAY 3, 2021, THERE APPEARS TO BE NO INDICATION OF ANY UNUSUAL ACTIVITY, ALARMS OR ALERTS. THE INSULIN PUMP MET MDT ACCURACY REQUIREMENTS PER 60601-2-24 VIA AN INFORMAL TEST. INSPECTION OF DELIVERY OVER A THREE DAY PERIOD SHOWS NO UNUSUAL DELIVERY PATTERNS. DEVICE PASSED FUNCTIONAL TESTING AND ADDITIONAL TESTING NOTED ABOVE. SEE ATTACHMENTS FOR SUPPORTING DATA. NOTE: BILL HODGE SPOKE WITH CUSTOMERS MOTHER CATHY LUCHT ON TUESDAY, NOVEMBER 23, 2021 AT ~12PM PST PER CATHY'S REQUEST. CATHY REQUESTED DESTRUCTIVE TESTING TO PERFORM AN INTERNAL VISUAL INSPECTION OF THE COMPONENTS. THE RESULTS OF THE INSPECTION ARE NOTED BELOW: THE INSULIN PUMP WAS CUT OPEN AND A VISUAL INSPECTION WAS PERFORMED. NO DAMAGE NOTED ON THE ELECTRONIC ASSEMBLY, MOTOR, FORCE SENSOR OR KEYPAD FLEX. HOWEVER, THERE WAS CORROSION NOTED AT THE END OF THE BATTERY TUBE UNDERNEATH THE POWER/VIBRATOR BOARD. FURTHER INSPECTION WITH A MICROSCOPE FOUND CORROSION NEAR THE BATTERY TUBE SPRING. 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.
DEVICE RECEIVED WITH A DEPLETED DURACELL ALKALINE BATTERY INSTALLED AT 1.039 VOLTS. DEVICE 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 DELIVERY ANALYSIS TEST. THE TEST RESERVOIR VOLUME MATCHES THE DEVICE LEFT IN THE PUMP STATUS SCREEN. NO DEVICE LEFT ANOMALY NOTED. NO UNEXPECTED EMPTY RESERVOIR ALARM OR UNEXPECTED AUDIO ALARM NOTED DURING TESTING. THE LOW RESERVOIR REMINDER WAS SET TO 25.0 UNITS. THE LOW RESERVOIR REMINDER FUNCTIONS PROPERLY. DEVICE UPLOADED PROPERLY USING CARELINK. DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, SCRATCHED SERIAL NUMBER LABEL AND A PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. 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.
(B)(4). 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 HAS BEEN UPDATED AND PROVIDED IN B5 SECTION OF THIS REPORT.
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 SUMMARY NARRATIVE HAS BEEN UPDATED IN SUMMARY AND PROVIDED IN SECTION B5 WITH THIS REPORT.
DEVICE RECEIVED WITH A DEPLETED DURACELL ALKALINE BATTERY INSTALLED AT 1.039 VOLTS. DEVICE 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 DELIVERY ACCURACY TEST. THE TEST RESERVOIR VOLUME MATCHES THE UNITS LEFT IN THE PUMP STATUS SCREEN. NO DEVICE LEFT ANOMALY NOTED. NO UNEXPECTED EMPTY RESERVOIR ALARM OR UNEXPECTED AUDIO ALARM NOTED DURING TESTING. THE LOW RESERVOIR REMINDER WAS SET TO 25.0 UNITS. THE LOW RESERVOIR REMINDER FUNCTIONS PROPERLY. DEVICE UPLOADED PROPERLY USING CARELINK. DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, SCRATCHED SERIAL NUMBER LABEL AND A PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. 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.
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 RELATED TO EVENT IN SUMMARY NARRATIVE WAS MISSING WHICH HAS BEEN PROVIDED IN SECTION B5 WITH THIS REPORT.
FOLLOW-UP FOR PUMP TO BE RETURNED WAS INITIATED. IT IS UNKNOWN IF SENSOR WAS USED AT THE TIME OF PASSING. IT IS UNKNOWN IF AUTO MODE WAS USED AT THE TIME OF PASSING.
THE CUSTOMER'S PARENT CALLED AND ADDED THAT THE POLICE FOUND THE CUSTOMER WITH THE PUMP ATTACHED TO THEIR BODY AND ALARMING WITH AN UNKNOWN ALARM. THE PUMP BATTERY GOT DEPLETED WHILE IN THE POSSESSION OF THE CORONER, AND WHEN A FRESH BATTERY WAS INSERTED ON (B)(6) 2021, THE PUMP WAS READING 100 UNITS REMAINING IN THE RESERVOIR. THE RESERVOIR HAD BEEN PREVIOUSLY REMOVED FROM THE PUMP BY THE CORONER WITHOUT SUSPENDING THE PUMP, UNTIL THE PUMP ALARMED THAT THE RESERVOIR WAS EMPTY. THE CALLER NOW SUSPECTS THAT THE PUMP MAY HAVE MALFUNCTIONED IN SOME UNKNOWN MANNER PRIOR TO THE CUSTOMER'S PASSING. THE CALLER SUSPECTS THE CUSTOMER WAS SUFFERING FROM DIABETIC KETOACIDOSIS DUE TO THE CUSTOMER BEING ILL PRIOR TO HIS PASSING. A CARELINK UPLOAD SHOWED THAT THE CUSTOMER BLOUSED 9 TIMES PRIOR TO PASSING. IT IS UNKNOWN IF THE CUSTOMER ACTUALLY HAD A LOW OR HIGH BLOOD GLUCOSE EVENT AT THE TIME OF PASSING. THE CUSTOMER PASSED AWAY AT HOME. THE CUSTOMER WAS NOT WEARING A SENSOR. THE CALLER AGREED TO RETURN THE PUMP FOR FAILURE ANALYSIS.
THE CUSTOMER'S PARENT CALLED AND ADDED THAT THE POLICE FOUND THE CUSTOMER WITH THE PUMP ATTACHED TO THEIR BODY AND ALARMING WITH AN UNKNOWN ALARM. THE PUMP BATTERY GOT DEPLETED WHILE IN THE POSSESSION OF THE CORONER, AND WHEN A FRESH BATTERY WAS INSERTED ON (B)(6) 2021, THE PUMP WAS READING 100 UNITS REMAINING IN THE RESERVOIR. THE RESERVOIR HAD BEEN PREVIOUSLY REMOVED FROM THE PUMP BY THE CORONER WITHOUT SUSPENDING THE PUMP, UNTIL THE PUMP ALARMED THAT THE RESERVOIR WAS EMPTY. THE CALLER NOW SUSPECTS THAT THE PUMP MAY HAVE MALFUNCTIONED IN SOME UNKNOWN MANNER PRIOR TO THE CUSTOMER'S PASSING. THE CALLER SUSPECTS THE CUSTOMER WAS SUFFERING FROM DIABETIC KETOACIDOSIS DUE TO THE CUSTOMER BEING ILL PRIOR TO HIS PASSING. A CARELINK UPLOAD SHOWED THAT THE CUSTOMER BOLUSED 9 TIMES PRIOR TO PASSING. IT IS UNKNOWN IF THE CUSTOMER ACTUALLY HAD A LOW OR HIGH BLOOD GLUCOSE EVENT AT THE TIME OF PASSING. THE CUSTOMER PASSED AWAY AT HOME. THE CUSTOMER WAS NOT WEARING A SENSOR. THE CALLER AGREED TO RETURN THE PUMP FOR FAILURE ANALYSIS.
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
CUSTOMER'S SON REPORTED VIA PHONE CALL THAT CUSTOMER PASSED AWAY ON (B)(6) 2021 AT HOME. IT WAS REPORTED THAT THE CUSTOMER WAS FOUND UNRESPONSIVE AND DEATH MAY HAVE BEEN DUE TO LOW BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE READING WAS UNKNOWN. THE EXACT CAUSE OF THE CUSTOMER'S PASSING WAS NOT YET KNOWN. THE INSULIN PUMP WAS WORN AT THE TIME OF DEATH. THE INSULIN PUMP WILL NOT BE RETURNED FOR FAILURE ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 651733 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | MEDTRONIC MINIMED | MMT-XXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Male | Other| D | FRN-RSVR,UNOMED INF SET.| FRN-RSVR,UNOMED INF SET |