PUMP 1886 780G OUS BLE PUMP MG/DL
Report
- Report Number
- 2032227-2024-126941
- Event Type
- Malfunction
- Date Received
- February 16, 2024
- Date of Event
- November 24, 2023
- Report Date
- February 16, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
S/W 6.7W RETAINER RING = BLACK CASE TYPE = NGP CUSTOMER RETURNED PUMP FOR ALLEGED PUMP ERROR 41, PUMP ERROR 43 AND COSMETIC DAMAGE LOCATED AT THE BACK OF THE PUMP FOUND ON (B)(6) 2023. THE PUMP PASSED THE FUNCTIONAL TEST, 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 AT 0.0872 INCHES. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA 1, PCBA 2 AND MOTOR. NO DAMAGE NOTED ON THE FORCE SENSOR. PUMP ERROR 41 ON (B)(6) 2023 AT 14:13:00.000 AND PUMP ERROR 43 ON (B)(6) 2023 AT 14:13:00.000 WERE FOUND IN THE PUMP HISTORY FILE, POSSIBLE HW. PUMP ERROR 41 CONFIRMED AND PUMP ERROR 43 CONFIRMED DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY AND ON THE MOTOR. THE PUMP WAS RECEIVED WITH A CASE AT CORNER OF THE BELT CLIP RAIL. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, FADED/SCRATCHED SERIAL NUMBER LABEL AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 24-NOV-2023 IN THE PUMP HISTORY FILE. (B)(6) 2023 10:51:04.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: MOTORMOTIONALARM (37) (B)(6) 2023 10:52:21.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 10:52:36.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 202310:52:49.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 10:53:03.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 10:54:35.000 BATTERYREMOVED (55) (B)(6) 2023 10:54:35.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2023 10:54:49.000 BATTERYINSERTED (44) (B)(6) 2023 10:54:49.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 10:55:01.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 10:55:13.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 202310:56:23.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 10:56:39.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 10:58:15.000 BATTERYREMOVED (55) (B)(6) 2023 10:58:15.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2023 10:58:28.000 BATTERYREMOVED (55) (B)(6) 2023 10:58:28.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2023 10:59:08.000 BATTERYINSERTED (44) (B)(6) 2023 10:59:08.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 10:59:17.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 10:59:31.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:09:00.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:09:14.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:09:30.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:09:43.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:10:02.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:11:16.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:11:31.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:17:56.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:18:12.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:18:25.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:18:39.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:18:52.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:19:06.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 202311:19:19.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:19:33.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:19:46.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:20:01.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:21:14.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:21:27.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:22:54.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:25:13.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 202311:25:27.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:25:41.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:26:16.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:26:32.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:31:15.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:35:16.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:35:31.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:36:19.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:43:16.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:44:17.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:44:40.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:48:15.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:50:16.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:57:14.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 11:59:14.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2023 12:02:46.000 BATTERYREMOVED (55) (B)(6) 2023 12:02:46.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2023 12:02:54.000 BATTERYINSERTED (44) (B)(6) 2023 12:02:55.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) THE PUMP PASSED THE FUNCTIONAL TESTING. NO PUMP ERROR 37 NOTED DURING TESTING. PUMP ERROR 37 CONFIRMED DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY AND ON THE MOTOR. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. FAILED BATTERY TEST ALARM WAS EXPECTED DUE TO THE CUSTOMER'S BATTERY INSERTED ON A BATTERY CHANGE DOES NOT HAVE SUFFICIENT VOLTAGE. PUMP ERROR 37 CONFIRMED. FAILEDBATTTEST (58) NOT CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. PUMP ERROR 41 CONFIRMED. PUMP ERROR 43 CONFIRMED. COSMETIC DAMAGE WAS CONFIRMED AT THE BACK OF THE PUMP. PUMP ERROR 37 CONFIRMED. "THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED OUTSIDE THE UNITED STATES. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. " 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 RECEIVED PUMP ERROR 43 AND PUMP ERROR 41. TROUBLESHOOTING WAS PERFORMED AND THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND THE REWIND PUMP SUCCESSFULLY. IT WAS ALSO REPORTED THAT PUMP HAD A CRACK IN THE CASE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP AND THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1299704 | PUMP 1886 780G OUS BLE PUMP MG/DL | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1886 | NG3242026H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Unknown |