630G INSULIN PUMP MMT-1715KL 630G
Report
- Report Number
- 2032227-2023-205424
- Event Type
- Malfunction
- Date Received
- May 10, 2023
- Date of Event
- April 26, 2023
- Report Date
- June 30, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- UDI-DI
- 000000763000316655
- PMA / PMN Number
- P150001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 003
Narratives
THE PUMP PASSED THE FUNCTIONAL TESTS, 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 DAT AT 0.08730 INCHES. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THERE WERE NO UNEXPECTED PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 26-APR-2023 IN THE FORMATTED HISTORY FILE. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 18:08:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 18:10:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 18:12:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 03:17:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 03:38:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 03:38:36.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 03:41:14.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING PRIME (B)(6) 2023 03:47:28.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 08:12:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 16:11:36.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 19:07:44.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 21:39:18.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 22:25:56.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 22:58:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 22:59:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 23:46:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 00:31:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 09:45:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 11:35:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 12:09:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 13:15:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 13:20:51.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 13:23:01.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 13:24:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 13:27:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 13:27:44.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 13:33:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING PRIME. (B)(6) 2023 13:40:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 13:45:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 13:48:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 13:50:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 14:04:51.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 16:54:04.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 23:07:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 23:46:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS 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.
(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 CUSTOMER RECEIVED INSULIN FLOW BLOCK ALARM AGAIN . NO FURTHER DETAILS WERE PROVIDED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE AND REVERT TO THE BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE PUMP WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 199121 | 630G INSULIN PUMP MMT-1715KL 630G | AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1715KL | HG5W0K4 | 000000763000316655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female |