640G INSULIN PUMP MMT-1711K
Report
- Report Number
- 2032227-2022-335286
- Event Type
- Malfunction
- Date Received
- September 14, 2022
- Date of Event
- September 21, 2020
- Report Date
- September 14, 2022
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- UDI-DI
- 000000643169554931
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- 003
Narratives
(B)(4). CUSTOMER RETURNED PUMP FOR AN ALLEGED PUMP ERROR ALARM FOUND ON (B)(6) 2020. PUMP WAS RECEIVED WITH A MISSING RESERVOIR TUBE O-RING, A BROKEN RESERVOIR TUBE LIP AND A MISSING RETAINER. PUMP WAS ALSO RECEIVED WITH A MISSING SEGMENTS/PARTIAL DISPLAY WITH VERTICAL LINES ON THE DISPLAY. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT. THE PUMP FAILED THE SELF TEST DUE TO MISSING SEGMENTS/PARTIAL DISPLAY WITH VERTICAL LINES ON THE DISPLAY. THE PUMP WAS MONITORED FOR SEVERAL HOURS, AND NO PUMP ERROR ALARM NOTED DURING THE TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE PUMP TRACE DOWNLOAD ANALYSIS CONFIRMED THE PUMP ALARMED PUMP ERROR , UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2020 02:52:32.000, (B)(6) 2020 06:11:45.000 (B)(6) 2020 10:30:29.000, (B)(6) 2020 10:40:01.000. REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2020 06:25:01.000, (B)(6) 2020 06:35:01.000 (B)(6) 2020 02:40:01.000, (B)(6) 2020 02:50:01.000 (B)(6) 2020 06:00:01.000, (B)(6) 2020 06:10:00.000 (B)(6) 2020 10:31:00.000. REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2020 06:56:01.000. (B)(6) 2020 07:06:01.000. PUMP ERROR 25 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2020 10:12:01.000. AND POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2020 10:42:11.000. THE POWER MANAGEMENT TOOL CONFIRMED PUMP ERROR ALARM, UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM. AFTER DISCONNECTING AND RECONNECTING THE INTERNAL BATTERY CONNECTOR ON J6/PCB 1, THE PUMP WAS MONITORED AND THE LOADED VOLTAGE (LOADED VLITH) AND THE UNLOADED VOLTAGE (UNLOADED VLITH) DISPLAY AT THE POWER GRAPH MANAGEMENT TOOL SHOWS ABNORMAL BEHAVIOR. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND A CRACKED LCD GLASS AND CORROSION ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. SLIGHT CORROSION WAS ALSO FOUND ON THE BATTERY TUBE ASSEMBLY. PUMP ERROR ALARM, UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM WERE CONFIRMED DUE TO CORROSION ON THE PCBA 1 AND PCBA 2. A MISSING SEGMENTS/PARTIAL DISPLAY WITH VERTICAL LINES ON THE DISPLAY WAS CONFIRMED DUE TO A CRACKED LCD GLASS. UNABLE TO LOCK A TEST P-CAP INTO THE RESERVOIR COMPARTMENT DUE TO A MISSING RETAINER, A MISSING RESERVOIR TUBE O-RING AND A BROKEN RESERVOIR TUBE LIP. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT, A SERIAL NUMBER LABEL MISSING AND A BROKEN BELT CLIP RAILS. A MISSING RETAINER, A MISSING RESERVOIR TUBE O-RING AND A BROKEN RESERVOIR TUBE LIP WERE CONFIRMED. A MISSING SEGMENTS/PARTIAL DISPLAY WITH VERTICAL LINES ON THE DISPLAY WAS CONFIRMED DUE TO A CRACKED LCD GLASS. PUMP ERROR ALARM, UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM WERE CONFIRMED DUE TO CORROSION ON THE PCBA 1 AND PCBA 2. DURING VISUAL INSPECTION, CORROSION WAS ALSO FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. SLIGHT CORROSION WAS ALSO FOUND ON THE BATTERY TUBE ASSEMBLY. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE NGP 640G INSULIN PUMP WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN 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 INSULIN PUMP HAD A POWER ERROR DETECTED. CUSTOMER WAS ABLE TO CLEAR ALARM AND ABLE COMPLETE REWIND PROCESS. NOTIFICATION LIGHT DID NOT STOP IMMEDIATELY FLASHING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT RETURN FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2496665 | 640G INSULIN PUMP MMT-1711K | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1711K | HG0N1HA | 000000643169554931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |