MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
Report
- Report Number
- 2032227-2023-264774
- Event Type
- Injury
- Date Received
- August 31, 2023
- Date of Event
- June 29, 2023
- Report Date
- November 3, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000414344
- PMA / PMN Number
- P150001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
THE PUMP PASSED THE FUNCTIONAL TESTS, 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 DAT AT 0.08730 INCHES. NO ABSENCE OF OCCLUSION ALARM/INSULIN FLOW BLOCKED ALARM NOTED DURING THE TESTING. THE INSULIN FLOW BLOCKED ALARM FUNCTIONING PROPERLY. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. THERE WAS ¿NO¿ NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE 29-JUN-2023. HOWEVER, NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND IN THE FORMATTED HISTORY FILE ON: 05/07/2023 09:59:53.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. 05/07/2023 10:09:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. 05/07/2023 10:19:55.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY.(B)(6) 2023 10:29:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. 05/07/2023 10:39:55.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. 05/07/2023 10:49:55.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. 05/12/2023 16:46:47.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 05/12/2023 16:47:36.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 05/12/2023 17:43:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. 05/12/2023 17:46:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. 05/12/2023 17:48:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. 05/12/2023 17:49:01.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. 05/13/2023 06:54:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. 05/13/2023 07:37:09.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 05/13/2023 08:02:25.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 05/17/2023 14:48:19.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 05/17/2023 14:48:57.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 05/23/2023 11:02:14.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 05/23/2023 11:02:32.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. 05/23/2023 11:04:45.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 07/03/2023 09:52:43.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 07/10/2023 08:03:09.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 07/10/2023 08:03:57.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 08/11/2023 16:02:35.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 08/11/2023 18:18:33.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 08/11/2023 19:09:15.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. 08/11/2023 19:11:09.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. NO UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 29-JUN-2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 29-JUN-2023 LISTED ON SMARTSOLVE. DAILYTOTALOFALLINSULINDELIVERED: 555750 (55.575 U) DAILYTOTALOFBASALINSULINDELIVERED: 226750 (22.675 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 329000 (32.9 U) 06/29/2023 11:12:23.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 152000 (15.2 U) BOLUSAMOUNTDELIVERED: 152000 (15.2 U) 06/29/2023 17:44:13.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 10000 (1 U) BOLUSAMOUNTDELIVERED: 10000 (1 U) 06/29/2023 19:27:21.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 136000 (13.6 U) BOLUSAMOUNTDELIVERED: 136000 (13.6 U) 06/29/2023 20:03:45.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 31000 (3.1 U) BOLUSAMOUNTDELIVERED: 31000 (3.1 U). THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 29-JUN-2023 IN THE FORMATTED HISTORY FILE. SENSOREXPIREDALERT (794) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 06/28/2023 21:36:28.000 LOSTSENSOR1ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 06/26/2023 00:47:00.000 06/26/2023 00:57:00.000 06/29/2023 16:49:00.000 06/29/2023 16:59:00.000 LOSTSENSOR2ALERT (781) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 06/29/2023 17:35:00.000 THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A 240 MG/DL GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 239 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SENSOR EXPIRED ALERT, LOST SENSOR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP WITH A BROKEN 1 HEAT STAKE POST. THE ORIGINAL BATTERY CAP LOCKS SECURELY INTO PLACE AND THE PUMP POWERED UP PROPERLY. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS AND DKA. ABSENCE OF OCCLUSION ALARM AND NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WERE 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 PUMP PASSED THE FUNCTIONAL TESTS, 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 DAT AT 0.08730 INCHES. NO ABSENCE OF OCCLUSION ALARM/INSULIN FLOW BLOCKED ALARM NOTED DURING THE TESTING. THE INSULIN FLOW BLOCKED ALARM FUNCTIONING PROPERLY. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. THERE WAS ¿NO¿ NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE 29-JUN-2023. HOWEVER, NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 09:59:53.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 10:09:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 10:19:55.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 10:29:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 10:39:55.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 10:49:55.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 16:46:47.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 16:47:36.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 17:43:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 17:46:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 17:48:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 17:49:01.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 06:54:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 07:37:09.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 08:02:25.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 14:48:19.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 14:48:57.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 11:02:14.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 11:02:32.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON (B)(6) 2023 11:04:45.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 09:52:43.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 08:03:09.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 08:03:57.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 16:02:35.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 18:18:33.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 19:09:15.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON (B)(6) 2023 19:11:09.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. NO UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 29-JUN-2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 29-JUN-2023 LISTED ON SMART SOLVE. DAILY TOTAL OF ALL INSULIN DELIVERED: 555750 (55.575 U). DAILY TOTAL OF BASAL INSULIN DELIVERED: 226750 (22.675 U). DAILY TOTAL OF BOLUS INSULIN DELIVERED: 329000 (32.9 U). ON (B)(6) 2023 11:12:23.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1). NORMAL BOLUS AMOUNT PROGRAMMED: 152000 (15.2 U). BOLUS AMOUNT DELIVERED: 152000 (15.2 U). ON (B)(6) 2023 17:44:13.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1). NORMAL BOLUS AMOUNT PROGRAMMED: 10000 (1 U). BOLUS AMOUNT DELIVERED: 10000 (1 U). ON (B)(6) 2023 19:27:21.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1). NORMAL BOLUS AMOUNT PROGRAMMED: 136000 (13.6 U). BOLUS AMOUNT DELIVERED: 136000 (13.6 U). ON (B)(6) 2023 20:03:45.000 NORMAL BOLUS DELIVERED (220). BOLUS PROGRAMMING METHOD: BOLUS WIZARD (1). NORMAL BOLUS AMOUNT PROGRAMMED: 31000 (3.1 U). BOLUS AMOUNT DELIVERED: 31000 (3.1 U). THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 29-JUN-2023 IN THE FORMATTED HISTORY FILE. SENSOR EXPIRED ALERT (794) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 21:36:28.000. LOST SENSOR 1 ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 00:47:00.000, ON (B)(6) 2023 00:57:00.000, ON (B)(6) 2023 16:49:00.000, ON (B)(6) 2023 16:59:00.000. LOST SENSOR 2 ALERT (781) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 17:35:00.000. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A 240 MG/DL GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 239 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SENSOR EXPIRED ALERT, LOST SENSOR ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP WITH A BROKEN 1 HEAT STAKE POST. THE ORIGINAL BATTERY CAP LOCKS SECURELY INTO PLACE AND THE PUMP POWERED UP PROPERLY. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS AND DKA. ABSENCE OF OCCLUSION ALARM AND NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WERE 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 RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND ALSO REPORTED THE INSULIN PUMP GOT INSULIN FLOW BLOCKED AND THE ABSENCE OF AN ALARM. TROUBLESHOOTING WAS NOT PERFORMED. AND IT WAS UNKNOWN WHETHER THE CUSTOMER USED THE DEVICE WITHIN 48 HOURS OF THE HIGH BLOOD GLUCOSE VALUE AND THE AUTO MODE FUTURE ACTIVATION IS ALSO UNKNOWN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER CONTINUED USING THE INSULIN PUMP AND THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1389938 | 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 | HG4Z6T4ZZ | 000000763000414344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Male | Required Intervention| H | FRN-MMT-332A-RSVR, UNOMED SET. |