PUMP MMT-1712KL 640G V4.10 BK SF MG
Report
- Report Number
- 2032227-2023-251042
- Event Type
- Malfunction
- Date Received
- August 8, 2023
- Date of Event
- July 16, 2023
- Report Date
- March 18, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- UDI-DI
- 000000763000317195
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- 003
Narratives
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 0.0873 INCHES. POSSIBLE UNDER DELIVERY ANOMALY NOT CONFIRMED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE BATTERY TUBE SIDE, SCRATCHED KEYPAD OVERLAY AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. THE PUMP WAS RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW FOR THE BOLUSES LISTED ON THE EVENT DATE 16-JUL-2023 IN THE PUMP HISTORY FILE. ON 07/16/2023 02:35:51.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 2.7. BOLUS AMOUNT DELIVERED = 2.7. ON 07/16/2023 06:41:00.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 1.2. BOLUS AMOUNT DELIVERED = 1.2. ON 07/16/2023 11:41:25.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 3. BOLUS AMOUNT DELIVERED = 3. ON 07/16/2023 12:35:00.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 1.7. BOLUS AMOUNT DELIVERED = 1.7. ON 07/16/2023 13:04:46.000 NORMAL BOLUS DELIVERED BOLUS PROGRAMMINGM ETHOD = BOLUS WIZARD. NORMAL BOLUSA MOUNT PROGRAMMED = 1.4. BOLUS AMOUNT DELIVERED = 1.4. ON 07/16/2023 13:49:24.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 1.1. BOLUS AMOUNT DELIVERED = 1.1. ON 07/16/2023 14:53:12.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 3.9. BOLUS AMOUNT DELIVERED = 3.9. ON 07/16/2023 16:35:24.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 2.4. BOLUS AMOUNT DELIVERED = 2.4. ON 07/16/2023 22:05:56.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 1.4. BOLUS AMOUNT DELIVERED = 1.4. ON 07/16/2023 22:14:32.000 NORMAL BOLUSD ELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 0.6. BOLUS AMOUNT DELIVERED = 0.6. PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE 16-JUL-2023 IN THE PUMP HISTORY FILE. ON 07/17/2023 00:00:00.000 DAILY TOTALS. DAILY TOTAL COLLECTION START TIME = 07/16/2023 00:00:00.000. DAILY TOTAL OF ALLI NSULIN DELIVERED = 42.175. DAILY TOTAL OF BASAL INSULIN DELIVERED = 22.775. DAILYT OTAL OF BOLUS INSULIN DELIVERED = 19.4. THERE WERE NO AUTO SUSPEND (12) ALARM NOTED IN THE PUMP HISTORY FILE. THERE WERE NO USER SUSPENDED ALARM NOTED ON THE EVENT DATE 16-JUL-2023 IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 16-JUL-2023 IN THE PUMP HISTORY FILE. ON 07/14/2023 13:47:00.000 ALARM ALERT NOTIFICATION. FAULT NUMBER = LOST SENSOR 1 ALERT (780). ON 07/16/2023 21:43:00.000 ALARM ALERT NOTIFICATION. FAULT NUMBER = LOST SENSOR 1 ALERT (780). THE PUMP PROPERLY CONNECTED WITH THE GUARDIAN 2 LINK TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 243 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY OR LOST SENSOR 1 ALERT NOTED. LOST SENSOR 1 ALERT (780) NOT CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS. POSSIBLE UNDER DELIVERY ANOMALY NOT CONFIRMED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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. 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 WHEN THE CUSTOMER ARRIVED AT THE HOSPITAL, HIS GLUCOSE LEVEL WAS 650 MG/DL, INDICATING HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS, AS WELL AS A POSITIVE KETONE VALUE AND SYMPTOMS OF NAUSEA, HEADACHE, AND SICKNESS. WHILE AT THE HOSPITAL, THE INDIVIDUAL WAS GIVEN AN IV INSULIN DRIP, INSULIN, PRAMIN, AND SOFRAN, AND THE BLOOD GLUCOSE LEVEL WAS 200 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER CLAIMED THAT THE HIGH BLOOD GLUCOSE WAS CAUSED BY INSULIN PUMP UNDER-DELIVERY SINCE BLOOD GLUCOSE DID NOT DROP EVEN AFTER BOLUS CORRECTION. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS. IT WAS ALSO FOUND THAT THE AUTO MODE FEATURE WAS NOT ACTIVE AT THE TIME OF THE EVENT. NO FURTHER CUSTOMER COMPLICATIONS WERE REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1466976 | PUMP MMT-1712KL 640G V4.10 BK SF MG | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1712KL | HG5WKE5 | 000000763000317195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Unknown |