PUMP MMT-1780KPK 670G PATHWAY BLACK MG
Report
- Report Number
- 2032227-2023-140130
- Event Type
- Malfunction
- Date Received
- February 2, 2023
- Date of Event
- January 17, 2023
- Report Date
- May 4, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- UDI-DI
- 000000763000190460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
PUMP RECEIVED WITH MISSING RETAINER RING. UNABLE TO LOCK A TEST P-CAP AND RESERVOIR INTO THE RESERVOIR COMPARTMENT DUE TO MISSING RETAINER RING. AFTER MULTIPLE BATTERY REPLACEMENT UNIT PERSISTED ON BLANK DISPLAY. PUMP RECEIVED WITH BLANK DISPLAY DUE TO CRACKED CASE BEHIND THE PUMP AT THE BATTERY COMPARTMENT CAUSING THE BATTERY TUBE TO BECOME LOOSE AND TEST BATTERY CAP NOT MAKING CONTACT TO THE BATTERY TUBE. THE BATTERY TUBE ASSEMBLY WAS PUSH BACK IN THE RIGHT POSITION, MONITORED AND NO BLANK DISPLAY NOTED. UNIT WAS DOWNLOADED SUCCESSFULLY USING (THUS SOFTWARE) FOR REFERENCE. PROCEED IT WITH THE FOLLOWING TESTING TO ASSURE PROPER FUNCTIONALITY OF THE UNIT. PUMP PASSED SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST. UNABLE TO PERFORM DISPLACEMENT TEST DUE TO MISSING RETAINER RING. NO BLANK DISPLAY, LOW BATTERY ALARMS OR UNEXPECTED BATTERY POWER LOSS NOTED DURING TESTING. THE POWER MANAGEMENT GRAPH IS WITHIN SPEC. UNIT ALSO RECEIVED WITH CRACKED CASE (BATTERY TUBE), CRACKED BATTERY TUBE THREADS, DETACHED RETAINER, BROKEN RESERVOIR TUBE LIP, MISSING RESERVOIR TUBE O-RING, MISSING DISPLAY WINDOW COVER, CRACKED KEYPAD AT SELECT BUTTON, KEYPAD OVERLAY TEXTURE DAMAGE AND SCRATCHED CASE. IN CONCLUSION, UNIT WAS RECEIVED WITH A BLANK DISPLAY DUE TO CRACKED CASE IN MULTIPLE LOCATIONS CAUSING THE BATTERY TUBE TO BECOME LOOSE AND TEST BATTERY CAP NOT MAKING CONTACT TO THE BATTERY TUBE. AFTER POSITIONING THE BATTERY TUBE IN PLACE UNIT POWERED BACK ON AND THE TESTING OF THE UNIT WAS SUCCESSFUL. 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.
(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.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED A BLANK DISPLAY AND DAMAGE TO THE INSULIN PUMP'S RETAINER RING. IT WAS ALSO FOUND THAT THE INSULIN PUMP WAS RECALLED. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE RESERVOIR WAS UNABLE TO LOCK IN PLACE WHEN INSERTED INTO THE PUMP. TROUBLESHOOTING WAS PERFORMED PARTIALLY AND LATER DECLINED FOR BLANK DISPLAY AND IT WAS UNKNOWN WHETHER THE ISSUE WAS RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE AND THE PUMP WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 955559 | PUMP MMT-1780KPK 670G PATHWAY BLACK MG | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1780KPK | HG3LLKS | 000000763000190460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Male |