PUMP MMT-1780KPK 670G PATHWAY BLACK MG
Report
- Report Number
- 2032227-2022-303347
- Event Type
- Malfunction
- Date Received
- July 28, 2022
- Date of Event
- July 25, 2022
- Report Date
- September 22, 2022
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000393786
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). 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.
TESTED WITH A TEST P-CAP AND THE TEST P-CAP LOCKED IN PLACE PROPERLY. UNIT PASSED DISPLACEMENT TEST, SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT, AND KEYPAD VOLTAGE TEST. ALL BUTTONS FUNCTION PROPERLY. NO STUCK BUTTON ALARM NOTED DURING TESTING. NO STUCK BUTTON ALARM LISTED IN PUMP HISTORY. PUMP WAS MONITORED. NO BLANK DISPLAY NOTED DURING TESTING. UNIT SUCCESSFULLY DOWNLOADED TO THUS. NO PUMP ERROR 43 ALARMS NOTED DURING TEST. VERIFIED IN THE PUMP HISTORY DOWNLOAD THE PUMP ALARMED PUMP ERROR 43 ON (B)(6) 2022 01:57:00.000 DUE TO MOISTURE DAMAGE. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. PUMP WAS CUT OPENED AND MOISTURE DAMAGE WAS NOTED ON PCB1, PCB2, AND MOTOR HOME SWITCH. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, SCRATCHED LCD WINDOW, CRACKED CASE, CRACKED BATTERY TUBE THREADS, STAINED KEYPAD OVERLAY, PILLOWING KEYPAD OVERLAY, CRACKED BATTERY TUBE CASE, SERIAL NUMBER LABEL DAMAGE, CORRODED BATTERY TUBE, MOISTURE DAMAGE, CORRODED MOTOR HOME SWITCH. PUMP ERROR 43 WAS CONFIRMED DUE TO MOISTURE DAMAGE TO PCB1 AND PCB2. BLANK DISPLAY NOT CONFIRMED. KEYPAD UNRESPONSIVE/BUTTON ERROR ALARM 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.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP BUTTON WAS UNRESPONSIVE AND HAD TO PUSH HARD FOR IT TO RESPOND. INSULIN PUMP HAD PUMP ERROR ALARM AND INSULIN PUMP DISPLAY WAS BLANK. CUSTOMER REPORTED THEY WERE NOT ABLE TO CLEAR THE ALARM. THE CUSTOMER STATED THAT PRESSING MENU BUTTON TAKES THEM TO THE MENU SCREEN AND USING THE UP ARROW ALLOWS THEM TO NAVIGATE SCREENS. CUSTOMER STATED THAT THE INSULIN PUMP WAS NEITHER DROPPED NOR EXPOSED TO MOISTURE. CUSTOMER STATED THAT BLOCK MODE WAS INACTIVE AND AN ALARM WAS NOT IN PROGRESS AT THE TIME THE BUTTON WAS UNRESPONSIVE ALSO BOLUS MENU IS AVAILABLE AND THEY ARE NOT SEEING 0.0 WHEN ATTEMPTING TO PROGRAM A BASAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2922926 | PUMP MMT-1780KPK 670G PATHWAY BLACK MG | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1780KPK | HG4LAGF | 000000763000393786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female |