670G INSULIN PUMP MMT-1780KL
Report
- Report Number
- 2032227-2022-118255
- Event Type
- Malfunction
- Date Received
- February 25, 2022
- Date of Event
- September 3, 2021
- Report Date
- January 29, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000283506
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). CUSTOMER RETURNED PUMP FOR AN ALLEGED COSMETIC DAMAGE LOCATED AT THE BATTERY COMPARTMENT, PUMP ERROR ALARM AND EXPOSURE TO MOISTURE FOUND ON (B)(6) 2021. PUMP RECEIVED WITH A CRACKED BATTERY TUBE THREADS AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. PUMP WAS ALSO RECEIVED WITH A MISSING SEGMENTS, PARTIAL DISPLAY. INSULIN PUMP FAILED THE SELF TEST DUE TO MISSING SEGMENTS/PARTIAL DISPLAY. PUMP PASSED THE ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08700 INCHES. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. PUMP ERROR ALARMS WERE RECORDED AND FOUND IN THE FORMATTED HISTORY FILES ON (B)(6) 202116:26:01.000 DUE TO RF DRIVER ANOMALY, SUSPECTED ON HW. PUMP ERROR ALARM (FILE NUMBER=26; LINE NUMBER=3041) CONFIRMED IN THE FORMATTED HISTORY FILE ON (B)(6) 2021 16:27:45.000, PROBLEM ISOLATED ON THE ELECTRONIC ASSEMBLY. 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 OR ALERTS NOTED DURING THE TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MISSING SEGMENTS/PARTIAL DISPLAY DUE TO CRACKED LCD GLASS. CORROSION WAS ALSO FOUND ON THE ELECTRICAL BOARD1, ELECTRICAL BOARD2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY. THE ORIGINAL ELECTRICAL BOARD1 WAS CLEANED AND INSTALLED IN A TEST ELECTRICAL BOARD2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL ELECTRICAL BOARD2 WAS CLEANED AND INSTALLED IN A TEST ELECTRICAL BOARD1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE SLEEP CURRENT MEASUREMENT. MISSING SEGMENTS/PARTIAL DISPLAY WAS CONFIRMED DUE TO CRACKED LCD GLASS. THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT DUE TO CORROSION ON THE ELECTRICAL BOARD1 AND ELECTRICAL BOARD2. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. COSMETIC DAMAGE WAS CONFIRMED AT THE BATTERY COMPARTMENT. MISSING SEGMENTS/PARTIAL WAS CONFIRMED DUE TO CRACKED LCD GLASS. PUMP ERROR ALARM, PUMP ERROR ALARMS AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WAS CONFIRMED. PUMP ERROR ALARM, PUMP ERROR ALARMS AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM DUE TO CORROSION ON THE ELECTRICAL BOARD1 AND ELECTRICAL BOARD2. DURING VISUAL INSPECTION, CORROSION WAS ALSO FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY. PUMP EXPOSED TO MOISTURE 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.
S/W VERSION 4.10E RETAINER RING = BLACK CUSTOMER RETURNED PUMP FOR AN ALLEGED COSMETIC DAMAGE LOCATED AT THE BATTERY COMPARTMENT, PUMP ERROR ALARM AND EXPOSURE TO MOISTURE FOUND ON SEPT 03, 2021. PUMP RECEIVED WITH A CRACKED BATTERY TUBE THREADS AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. PUMP WAS ALSO RECEIVED WITH A MISSING SEGMENTS/PARTIAL DISPLAY. PUMP FAILED THE SELF TEST DUE TO MISSING SEGMENTS/PARTIAL DISPLAY. PUMP PASSED THE ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08700 INCHES. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM WITH (VARIABLE=21) WERE RECORDED AND FOUND IN THE FORMATTED HISTORY FILES ON (B)(6) 2021 16:26:01.000 DUE TO RF DRIVER ANOMALY, SUSPECTED ON HW. PUMP ERROR 53 ALARM (FILE NUMBER=26; LINE NUMBER=3041) CONFIRMED IN THE FORMATTED HISTORY FILE ON (B)(6) 2021 16:27:45.000, PROBLEM ISOLATED ON THE ELECTRONIC ASSEMBLY. 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 OR ALERTS NOTED DURING THE TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MISSING SEGMENTS/PARTIAL DISPLAY DUE TO CRACKED LCD GLASS. CORROSION WAS ALSO FOUND ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY. THE ORIGINAL PCBA1 WAS CLEANED AND INSTALLED IN A TEST PCBA2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA2 WAS CLEANED AND INSTALLED IN A TEST PCBA1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE SLEEP CURRENT MEASUREMENT. MISSING SEGMENTS/PARTIAL DISPLAY WAS CONFIRMED DUE TO CRACKED LCD GLASS. THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT DUE TO CORROSION ON THE PCBA1 AND PCBA2. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. COSMETIC DAMAGE WAS CONFIRMED AT THE BATTERY COMPARTMENT. MISSING SEGMENTS/PARTIAL WAS CONFIRMED DUE TO CRACKED LCD GLASS. PUMP ERROR 4 ALARM, PUMP ERROR 63 ALARM, PUMP ERROR 53 ALARM AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WAS CONFIRMED. PUMP ERROR 4 ALARM, PUMP ERROR 63 ALARM, PUMP ERROR 53 ALARM AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM DUE TO CORROSION ON THE PCBA1 AND PCBA2. DURING VISUAL INSPECTION, CORROSION WAS ALSO FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY. PUMP EXPOSED TO MOISTURE 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. THE INFORMATION THAT PROVIDED WITH THE INITIAL REPORT WAS INCORRECT. THE CORRECT INFORMATION HAS BEEN INCLUDED WITH THIS REPORT IN B5 SECTION.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD DAMAGE ON THE BATTERY COMPARTMENT. CUSTOMER REPORTED PUMP ERROR AND EXPOSED OF MOISTURE DAMAGED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED SUCCESSFULLY HOWEVER, THE CUSTOMER WILL DISCONTINUE THE USE OF DEVICE.
THE DEVICE WAS RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1486522 | 670G INSULIN PUMP MMT-1780KL | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1780KL | HG3SS69 | 000000763000283506 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Female |