PUMP 1886 780G OUS BLE PUMP MG/DL
Report
- Report Number
- 2032227-2024-120478
- Event Type
- Death
- Date Received
- February 5, 2024
- Date of Event
- August 30, 2023
- Report Date
- February 5, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. THE PUMP PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08690 INCHES. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 07-AUG-2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS AND NO BOLUS DELIVERY NOTED. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 07-AUG-2023 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: 08/07/2023 00:00:00.000. DAILY TOTAL OF ALL INSULIN DELIVERED: 132750 (13.275 U). DAILY TOTAL OF BASAL INSULIN DELIVERED: 132750 (13.275 U). DAILY TOTAL O FBOLUS INSULIN DELIVERED: 0 (0 U). IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 30-AUG-2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS AND NO BOLUS DELIVERY NOTED. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 30-AUG-2023 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: 08/30/2023 00:00:00.000. DAILY TOTAL OF ALL INSULIN DELIVERED: 0 (0 U). DAILY TOTAL OF BASAL INSULIN DELIVERED: 0 (0 U). DAILY TOTAL OF BOLUS INSULIN DELIVERED: 0 (0 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 DATES OF 07-AUG-2023 AND 30-AUG-2023 IN THE FORMATTED HISTORY FILE. LOST SENSOR 1 ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/01/2023 11:20:00.000; 08/01/2023 11:30:00.000. LOST SENSOR 2 ALERT (781) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/01/2023 12:14:00.000; 08/01/2023 12:24:00.000. SENSOR ERROR ALERT (801) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/07/2023 19:28:05.000; 08/07/2023 19:38:00.000; 08/07/2023 20:03:07.000; 08/07/2023 20:13:00.000; 08/07/2023 20:38:07.000. SENSOR SIGNAL NOT FOUND (796) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/01/2023 13:04:00.000. 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 LOST SENSOR ALERT, SENSOR ERROR ALERT, SENSOR SIGNAL NOT FOUND OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. 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. NO ALARMS/ALERTS WERE NOTED. NO POWER ERROR 25 ALARM, LOW BATTERY ALERT, POWER LOSS ALARM, REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM WERE FOUND IN THE HISTORY FILES OR TRACES ON THE EVENT DATES OF HOWEVER, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/04/2023 03:18:00.000; 08/25/2023 00:03:00.000. REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/04/2023 12:49:00.000. REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/04/2023 13:20:00.000; 08/04/2023 13:30:00.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/04/2023 13:34:49.000. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/25/2023 08:34:30.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 16-SEP-2023 AT 2:04:57 AM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATES OF 04-AUG-2023 AND 25-AUG-2023. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE ORIGINAL PCBA 2 WAS INSTALLED IN A TEST PCBA 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN A TEST PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN THE ORIGINAL PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE PUMP HAD AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS), SUSPECTED ON THE PCBA 1/PCBA 2. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.1 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE THE PUMP WAS RECEIVED WITHOUT A BATTERY CAP INSTALLED. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. PLEASE SEE BELOW FOR THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE SS EVENT DATE 30-AUG-2023 LISTED ON SMARTSOLVE AND THE DAYS PRIOR TO THE EVENT DATE. 08/21/2023: DAILY TOTAL OF ALL INSULIN DELIVERED: 0 (0 U). 08/22/2023: DAILY TOTAL OF ALL INSULIN DELIVERED: 0 (0 U). 08/23/2023: DAILY TOTAL OF ALL INSULIN DELIVERED: 0 (0 U). 08/24/2023: DAILY TOTAL OF ALL INSULIN DELIVERED: 0 (0 U). 08/25/2023: DAILY TOTAL OF ALL INSULIN DELIVERED: 0 (0 U). 08/26/2023: DAILY TOTAL OF ALL INSULIN DELIVERED: 0 (0 U). 08/27/2023: DAILY TOTAL OF ALL INSULIN DELIVERED: 0 (0 U). 08/28/2023 : DAILY TOTAL OF ALL INSULIN DELIVERED: 0 (0 U). 08/29/2023: DAILY TOTAL OF ALL INSULIN DELIVERED: 0 (0 U). 08/30/2023: DAILY TOTAL OF ALL INSULIN DELIVERED: 0 (0 U). UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WAS CONFIRMED, SUSPECTED ON THE PCBA 1/PCBA 2. 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 PASSED AWAY ON (B)(6) 2023. THE CAUSE OF DEATH WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED, AND IT WAS UNCLEAR IF THE INSULIN PUMP SYSTEM WAS USED WITHIN 48 HOURS OF PASSED AWAY. THE PRODUCT WAS RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 495450 | PUMP 1886 780G OUS BLE PUMP MG/DL | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1886 | NG3199301H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Unknown | Death |