PUMP MMT-1782KL 670G MM RPL
Report
- Report Number
- 2032227-2023-211861
- Event Type
- Injury
- Date Received
- June 1, 2023
- Date of Event
- May 4, 2023
- Report Date
- October 3, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000365905
- PMA / PMN Number
- P160017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
CUSTOMER RETURNED PUMP FOR AN ALLEGED POSSIBLE UNDER DELIVERY AND WAS HOSPITALIZED FOR HIGH BGS AND DKA FOUND ON (B)(6) 2023 (PER SS EVENT DATE). HOWEVER, THE CUSTOMER'S NOTE STATED THAT THE CUSTOMER RETURNED PUMP FOR AN ALLEGED POSSIBLE UNDER DELIVERY AND WAS HOSPITALIZED FOR HIGH BGS AND DKA FOUND ON (B)(6) 2023. ON (B)(4), SVN#: (B)(4) - CUSTOMER RETURNED PUMP FOR AN ALLEGED BATTERY CAP CONTACT MISSING/DAMAGED AND BLANK DISPLAY FOUND ON (B)(6) 2022 UNABLE TO CONFIRM BATTERY CAP CONTACT MISSING/DAMAGED DUE TO PUMP RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. A TEST BATTERY CAP LOCKS SECURELY INTO PLACE. THE PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. 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 (B)(4). THE PUMP WAS MONITORED FOR SEVERAL DAYS AND NO BLANK DISPLAY NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM (B)(6) 2023 TO (B)(6) 2023. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED ALARMS/SUSPENDS AND BOLUS DELIVERY FOR THE EVENT DATE OF 03-SEP-2022. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED PUMP ERRORS/ALARMS 1 WEEK PRIOR TO THE EVENT DATE 03-SEP-2022 IN THE FORMATTED HISTORY FILE. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE SS EVENT DATE OF 04-MAY-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 04-MAY-2023 LISTED ON SMARTSOLVE. DAILYTOTALOFALLINSULINDELIVERED = 0 DAILYTOTALOFBASALINSULINDELIVERED = 0 DAILYTOTALOFBOLUSINSULINDELIVERED = 0 IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE SS EVENT DATE OF 02-MAY-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 02-MAY-2023 LISTED ON SMARTSOLVE. DAILYTOTALOFALLINSULINDELIVERED = 101.15 DAILYTOTALOFBASALINSULINDELIVERED = 52.325 DAILYTOTALOFBOLUSINSULINDELIVERED = 48.825 (B)(6) 2023 08:41:37.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 9.15 BOLUSAMOUNTDELIVERED = 9.15 (B)(6) 2023 10:16:37.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 4.425 BOLUSAMOUNTDELIVERED = 4.425 (B)(6) 2023 11:21:36.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 2.2 BOLUSAMOUNTDELIVERED = 2.2 (B)(6) 2023 15:15:24.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 9.75 BOLUSAMOUNTDELIVERED = 9.75 (B)(6) 2023 16:58:52.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 1.775 BOLUSAMOUNTDELIVERED = 1.775 (B)(6) 2023 18:01:54.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 2.75 BOLUSAMOUNTDELIVERED = 2.75 (B)(6) 2023 19:07:12.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 7.05 BOLUSAMOUNTDELIVERED = 7.05 (B)(6) 2023 20:43:11.000 NORMALBOLUSDELIV BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 2.975 BOLUSAMOUNTDELIVERED = 2.975 (B)(6) 2023 22:35:57.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 6.3 BOLUSAMOUNTDELIVERED = 6.3 (B)(6) 2023 23:21:12.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 2.45 BOLUSAMOUNTDELIVERED = 2.45 THERE WAS NO 20 U BOLUS RECORDED IN THE FORMATTED HISTORY FILE FOR THE SS EVENT DATE 04-MAY-2023 AND CUSTOMER EVENT DATE 02-MAY-2023. THERE WAS NO 20 U BOLUS RECORDED IN THE FORMATTED HISTORY FILE BEFORE AND AFTER THE EVENT DATES 02-MAY-2023 AND 04-MAY-2023. 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. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED DURING TESTING. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 02-MAY-2023 AND 04-MAY-2023 IN THE FORMATTED HISTORY FILE. LOST SENSOR 1 ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 19:20:00.000 SG CALIBRATION ERROR (776) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 07:27:07.000 CANNOT FIND SENSOR SIGNAL 1 ALERT (790) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 19:28:00.000 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 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO LOST SENSOR 1 ALERT, SG CALIBRATION ERROR, CANNOT FIND SENSOR SIGNAL 1 ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 23:06:46.000 (B)(6) 2023 23:16:00.000 (B)(6) 2023 23:18:49.000 (B)(6) 2023 23:28:00.000 PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 23:17:04.000 (B)(6) 2023 23:29:04.000 POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 23:17:25.000 (B)(6) 2023 23:17:36.000 (B)(6) 2023 23:31:40.000 (B)(6) 2023 23:31:51.000 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. NO ALARMS/ALERTS WERE NOTED. NO POWER ERROR 25, LOW BATTERY ALERT AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM NOTED 1 WEEK PRIOR TO THE EVENT DATE 02-MAY-2023 AND 04-MAY-2023 IN THE FORMATTED HISTORY FILE. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE PUMP RESETS AFTER THE BATTERY WAS REMOVED FOR MORE THAN 10 MINUTES. PUMP WAS MONITORED WITHOUT THE TEST ENERGIZER BATTERY INSIDE THE BATTERY COMPARTMENT AND REINSERTS IT BACK INTO THE BATTERY COMPARTMENT FOR LESS THAN 10 MINUTES AND NO UNEXPECTED PUMP ERROR 23 ALARM NOTED. NO UNEXPECTED POWER LOSS ALARM NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.5 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. 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 CRACKED KEYPAD OVERLAY, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING. BATTERY CAP CONTACT MISSING/DAMAGED WAS UNKNOWN. BLANK DISPLAY WAS NOT CONFIRMED. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS AND DKA. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. CUSTOMER ALLEGED FOR POSSIBLE UNDER DELIVERY WAS 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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 EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 28 MMOL/L AT THE TIME OF THE EVENT. CUSTOMER ALSO REPORTED THAT WHEN 20 UNITS OF INSULIN WAS DELIVERED, THE RESERVOIR AND VIAL WAS CHECKED AND FOUND THAT INSULIN WAS DELIVERED BUT THE AMOUNT WAS NOT ENOUGH BY LOOKING AT THE RESERVOIR.. THE CUSTOMER WAS TREATED IN HOSPITAL. THE CUSTOMER ALSO EXPERIENCED DIABETIC KETOACIDOSIS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER USED THE SMARTGUARD AUTO MODE OF THE INSULIN PUMP. 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 |
|---|---|---|---|---|---|---|---|
| 1030089 | PUMP MMT-1782KL 670G MM RPL | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1782KL | HG5DJJL | 000000763000365905 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization | FRN-MMT-332A-RSVR,UNOMED INF SET,MMT-7020C5-SNSR. |