MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L
Report
- Report Number
- 2032227-2024-138518
- Event Type
- Malfunction
- Date Received
- March 8, 2024
- Date of Event
- February 19, 2024
- Report Date
- April 2, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000734435
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
THE PUMP PASSED THE SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08730 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND IN THE FORMATTED HISTORY FILE ON: 02/18/2024 04:45:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 04:55:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 08:21:33.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 10:42:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 10:52:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 11:01:37.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 11:06:12.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 11:07:58.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING PRIME. ON 02/18/2024 11:11:28.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 11:16:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 11:21:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 11:26:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 11:31:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 11:36:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 11:41:35.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 11:46:25.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 11:56:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 12:01:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 12:16:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 12:26:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 12:36:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 12:46:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 13:26:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 13:31:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 15:31:31.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 15:36:31.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 15:41:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 15:46:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 15:51:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 15:56:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 16:01:25.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 16:06:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 16:11:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 16:16:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 16:21:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 16:26:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 16:31:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 16:36:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 16:41:31.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 16:46:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 16:51:25.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 16:56:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 17:01:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 17:11:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 17:21:00.000 ALARM ALERT NOTIFICATION (40) FAULTN UMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 17:21:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 17:31:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 17:36:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 17:41:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 17:46:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 17:56:31.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NOD ELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 18:01:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 18:06:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 18:11:31.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 18:16:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 18:21:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 18:51:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 18:56:28.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 19:31:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 19:36:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 19:41:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 19:46:27.000 ALARMA LERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 19:51:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 19:56:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 20:01:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 20:06:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 20:11:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 21:01:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 21:06:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 21:11:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 21:16:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 21:21:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NODELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 21:26:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 21:31:29.000 ALARM ALERTN OTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 21:36:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 21:41:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 21:46:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 21:51:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 21:56:31.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 22:01:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 22:06:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 22:11:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 22:16:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 22:21:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 22:26:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 22:31:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 22:36:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 22:41:28.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/18/2024 22:46:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 22:51:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 22:56:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 23:01:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 23:06:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NODELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 23:11:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 23:16:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 23:21:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 23:26:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 23:31:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 23:36:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 23:41:31.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 23:46:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 23:51:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/18/2024 23:56:27.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/19/2024 00:01:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/19/2024 00:06:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/19/2024 00:11:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/19/2024 00:16:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/19/2024 00:36:31.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/19/2024 00:41:28.000 ALARM ALERT NOTIFICATION (40) FAULTNUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/19/2024 00:46:33.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/19/2024 00:51:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/19/2024 00:56:31.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/19/2024 01:01:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/19/2024 01:06:31.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. ON 02/19/2024 01:11:29.000 ALARM ALERTN OTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 01:21:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 01:26:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 02:16:33.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 02:26:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 08:41:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 08:51:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 09:30:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 12:13:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 12:32:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: NODELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 12:35:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 12:38:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 13:23:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 13:25:00.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 14:41:31.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 14:46:33.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 14:51:33.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 14:56:33.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 15:01:33.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 15:06:31.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 15:11:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 15:16:31.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 15:21:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BASAL DELIVERY. ON 02/19/2024 15:26:29.000 ALARM ALERT NOTIFICATION (40) FAULT NUMBER: NO DELIVERY (7) DURING BOLUS DELIVERY. 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 UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 2 DAYS PRIOR TO THE EVENT DATE 19-FEB-2024 IN THE FORMATTED HISTORY FILE. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/18/2024 18:56:00.000. REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/19/2024 04:27:00.000. REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/19/2024 04:58:00.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 02/19/2024 08:25:28.000. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER. THE CUSTOMER MAY HAVE USED A LOW POWER BATTERY. THE MOLDING KNIT LINE DAMAGE (NEAR THE BELT CLIP PLATE) WAS ACCEPTABLE PER CASE ASSEMBLY COSMETIC SPECIFICATION, (B)(4). THE SC1 CAP LOCKS PROPERLY INTO THE RESERVOIR COMPARTMENT. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. CUSTOMER ALLEGED FOR NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED OUTSIDE THE UNITED STATES. 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 RECEIVED UNEXPLAINED/RANDOM NO-DELIVERY ALERTS. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED RECURRING INSULIN FLOW BLOCKED ALARMS AFTER TROUBLESHOOTING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DISCONTINUED USING THE PUMP AND IT WILL BE RETURNED FOR PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 909003 | MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1885 | NG3513797H | 000000763000734435 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Unknown |