PUMP MMT-1880L MM770G BLE MG
Report
- Report Number
- 2032227-2023-299052
- Event Type
- Malfunction
- Date Received
- November 8, 2023
- Date of Event
- October 21, 2023
- Report Date
- December 28, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000578640
- PMA / PMN Number
- P160017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- 003
Narratives
THE PUMP PASSED ALL FUNCTIONAL TESTING 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 DAT TEST AT .08695 INCHES. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. NO UNDER-DELIVERY ANOMALY WAS NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), MOTOR, OR FORCE SENSOR. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE PUMP PASSED ALL FUNCTIONAL TESTING. UNDER-DELIVERY AND HIGH BG ANOMALIES ARE NOT CONFIRMED. THE PUMP HISTORY FILE LISTS 14 BOLUSES ON THE EVENT DATE, 10/21/2023, LISTED BELOW: 10/21/2023 01:15:31.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: MANUAL BOLUS (0) NORMAL BOLUS AMOUNT PROGRAMMED: 8000 (0.8 U) BOLUS AMOUNT DELIVERED: 8000 (0.8 U) 10/21/2023 04:07:42.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: MANUAL BOLUS (0) NORMAL BOLUS AMOUNT PROGRAMMED: 33000 (3.3 U) BOLUS AMOUNT DELIVERED: 33000 (3.3 U) 10/21/2023 07:21:28.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: MANUALBOLUS (0) NORMAL BOLUS AMOUNT PROGRAMMED: 29000 (2.9 U) BOLUSA MOUNT DELIVERED: 29000 (2.9 U) 10/21/2023 08:50:02.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: MANUAL BOLUS (0) NORMAL BOLUS AMOUNT PROGRAMMED: 11000 (1.1 U) BOLUSA MOUNT DELIVERED: 11000 (1.1 U) 10/21/2023 10:25:10.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: MANUALBOLUS (0) NORMAL BOLUSA MOUNT PROGRAMMED: 24000 (2.4 U) BOLUSA MOUN TDELIVERED: 24000 (2.4 U) 10/21/2023 10:57:40.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 34000 (3.4 U) BOLUSAMOUNTDELIVERED: 34000 (3.4 U) 10/21/2023 11:54:08.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMAL BOLUS AMOUNT PROGRAMMED: 32000 (3.2 U) BOLUS AMOUNT DELIVERED: 32000 (3.2 U) 10/21/2023 12:21:20.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: MANUAL BOLUS (0) NORMAL BOLUS AMOUNT PROGRAMMED: 27000 (2.7 U) BOLUS AMOUNT DELIVERED: 27000 (2.7 U) 10/21/2023 14:23:38.000 NORMAL BOLUS DELIVERED (220) BOLUS PROGRAMMING METHOD: MANUAL BOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 35000 (3.5 U) BOLUSAMOUNTDELIVERED: 35000 (3.5 U) 10/21/2023 15:24:45.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 37000 (3.7 U) BOLUSAMOUNTDELIVERED: 37000 (3.7 U) 10/21/2023 16:18:52.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 36000 (3.6 U) BOLUSAMOUNTDELIVERED: 36000 (3.6 U) 10/21/2023 18:46:42.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 9000 (0.9 U) BOLUSAMOUNTDELIVERED: 9000 (0.9 U) 10/21/2023 21:13:25.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 30000 (3 U) BOLUSAMOUNTDELIVERED: 30000 (3 U) 10/21/2023 23:43:48.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: MANUALBOLUS (0) NORMALBOLUSAMOUNTPROGRAMMED: 29000 (2.9 U) BOLUSAMOUNTDELIVERED: 29000 (2.9 U) PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE, 10/21/2023: 10/22/2023 00:00:00.000 DAILYTOTALSG670 (63) DAILY TOTAL COLLECTION STARTTIME: 10/21/2023 00:00:00.000 DAILY TOTAL OF ALL INSULIN DELIVERED: 421500 (42.15 U) DAILY TOTAL OF BASAL INSULIN DELIVERED: 47500 (4.75 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 374000 (37.4 U) THERE WERE NO AUTO SUSPEND EVENTS ON THE EVENT DATE, 10/21/2023. PLEASE SEE BELOW FOR THE USER SUSPEND ON THE EVENT DATE, 10/21/2023: 10/21/2023 10:25:26 INSULINDELIVERYSTOPPED EVENTTYPE = 30 REASONFORINSULINDELIVERYSUSPENSION = USER SUSPENDED 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. 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 287 MG/DL AND WAS TREATED WITH MANUAL INJECTION. CUSTOMER'S BLOOD GLUCOSE VALUE AT THE TIME OF CALL WAS 260 MG/DL. CUSTOMER DIDN'T EXPERIENCED ANY SYMPTOMS DUE TO HIGH BLOOD GLUCOSE. IN ADDITION TO THAT CUSTOMER REPORTED BLOOD GLUCOSE NOT GOING DOWN WITH DOUBLE DOSAGE OF INSULIN. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE PUMP WAS USED WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT AND THE AUTO MODE FEATURE WAS NOT ACTIVE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 743719 | PUMP MMT-1880L MM770G BLE MG | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1880L | NG3562725H | 000000763000578640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female |