PUMP MMT-1885A OUS BLE PUMP MMOL/L
Report
- Report Number
- 2032227-2023-318686
- Event Type
- Injury
- Date Received
- December 20, 2023
- Date of Event
- November 27, 2023
- Report Date
- February 12, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
THE PUMP PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08730 INCHES. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 02-NOV-2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 02-NOV-2023 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: 11/02/2023 00:00:00.000. DAILYTOTALOFALLINSULINDELIVERED: 452500 (45.25 U). DAILYTOTALOFBASALINSULINDELIVERED: 114000 (11.4 U). DAILYTOTALOFBOLUSINSULINDELIVERED: 338500 (33.85 U). 11/02/2023 00:11:23.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 11750 (1.175 U), BOLUSAMOUNTDELIVERED: 11750 (1.175 U). 11/02/2023 01:46:22.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1AUTOBOLUS (9), NORMALBOLUSAMOUNTPROGRAMMED: 11250 (1.125 U), BOLUSAMOUNTDELIVERED: 11250 (1.125 U). 11/02/2023 04:06:19.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1AUTOBOLUS (9), NORMALBOLUSAMOUNTPROGRAMMED: 3000 (0.3 U), BOLUSAMOUNTDELIVERED: 3000 (0.3 U). 11/02/2023 06:11:21.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1AUTOBOLUS (9), NORMALBOLUSAMOUNTPROGRAMMED: 2250 (0.225 U), BOLUSAMOUNTDELIVERED: 2250 (0.225 U). 11/02/2023 06:56:19.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1AUTOBOLUS (9), NORMALBOLUSAMOUNTPROGRAMMED: 2500 (0.25 U), BOLUSAMOUNTDELIVERED: 2500 (0.25 U). 11/02/2023 07:28:22.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: CL1GLUCOSECORRECTIONPLUSFOODBOLUS (8), NORMALBOLUSAMOUNTPROGRAMMED: 49250 (4.925 U), BOLUSAMOUNTDELIVERED: 49250 (4.925 U). 11/02/2023 13:00:26.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 80750 (8.075 U), BOLUSAMOUNTDELIVERED: 80750 (8.075 U). 11/02/2023 15:16:40.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 74000 (7.4 U), BOLUSAMOUNTDELIVERED: 74000 (7.4 U). 11/02/2023 17:11:13.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 45750 (4.575 U), BOLUSAMOUNTDELIVERED: 45750 (4.575 U). 11/02/2023 20:39:44.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 58000 (5.8 U), BOLUSAMOUNTDELIVERED: 58000 (5.8 U). IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF 27-NOV-2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE 27-NOV-2023 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: 11/27/2023 00:00:00.000. DAILYTOTALOFALLINSULINDELIVERED: 391750 (39.175 U). DAILYTOTALOFBASALINSULINDELIVERED: 176500 (17.65 U). DAILYTOTALOFBOLUSINSULINDELIVERED: 215250 (21.525 U). 11/27/2023 07:54:13.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 58750 (5.875 U), BOLUSAMOUNTDELIVERED: 58750 (5.875 U). 11/27/2023 08:58:23.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 32250 (3.225 U), BOLUSAMOUNTDELIVERED: 32250 (3.225 U), 11/27/2023 10:20:47.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 41000 (4.1 U), BOLUSAMOUNTDELIVERED: 41000 (4.1 U). 11/27/2023 10:21:57.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 250 (0.025 U), BOLUSAMOUNTDELIVERED: 250 (0.025 U). 11/27/2023 13:46:57.000 NORMALBOLUSDELIVERED (2, BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 56000 (5.6 U), BOLUSAMOUNTDELIVERED: 56000 (5.6 U). 11/27/2023 13:54:45.000 NORMALBOLUSDELIVERED (220), BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1), NORMALBOLUSAMOUNTPROGRAMMED: 27000 (2.7 U), BOLUSAMOUNTDELIVERED: 27000 (2.7 U). 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 BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATES OF 02-NOV-2023 AND 27-NOV-2023 IN THE FORMATTED HISTORY FILE. SENSOREXPIREDALERT (794) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/28/2023 17:39:40.000, 10/28/2023 17:49:00.000. LOSTSENSOR1ALERT (780) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/29/2023 00:33:00.000, 11/02/2023 08:27:00.000, 11/02/2023 09:57:00.000, 11/02/2023 19:11:00.000, 11/02/2023 19:21:00.000, 11/24/2023 11:56:00.000, 11/26/2023 23:52:00.000, 11/27/2023 00:02:00.000, 11/27/2023 08:44:00.000. LOSTSENSOR2ALERT (781) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/29/2023 00:50:00.000, 10/29/2023 01:00:00.000, 11/02/2023 08:49:00.000, 11/02/2023 10:19:00.000, 11/02/2023 19:37:00.000, 11/27/2023 00:18:00.000, 11/27/2023 09:00:00.000. SGCALIBRATIONERROR (776) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 11/23/2023 20:26:30.000. SENSORSIGNALNOTFOUND (796) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/29/2023 12:22:00.000, 11/02/2023 09:21:00.000, 11/02/2023 20:54:00.000. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A 240 MG/DL GLUCOSE SENSOR SIMULATOR. THE PUMP CONNECTED SUCCESSFULLY TO THE TRANSMITTER AND DISPLAYED ¿TRANSMITTER CONNECTION SUCCESSFUL¿. THE PUMP COMMUNICATED PROPERLY WITH GLUCOSE SENSOR SIMULATOR AND DISPLAYED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE WARM UP. THE PUMP CALIBRATED AND DISPLAYED THE PROGRAMMED VALUE OF 240 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SENSOREXPIREDALERT , LOST SENSOR ALERT, SG CALIBRATION ERROR, SENSOR SIGNAL NOT FOUND OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS/ALERTS WERE NOTED. HOWEVER, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/30/2023 17:32:00.000. REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/31/2023 03:03:00.000, 10/31/2023 03:13:00.000. REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/31/2023 03:34:00.000, 10/31/2023 03:44:00.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/31/2023 07:25:19.000. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON 04-DEC-2023 AT 3:11:53 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATES OF 30-OCT-2023 AND 31-OCT-2023. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM. NO UNEXPECTED LOW BATTERY ALERT, REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM AND POWER LOSS ALARM NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND SLIGHT CORROSION ON THE PCBA 1 AND PCBA 2. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE ORIGINAL PCBA 2 WAS CLEANED, INSTALLED IN A TEST PCBA 1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS CLEANED, INSTALLED IN A TEST PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA 1 WAS INSTALLED IN THE ORIGINAL PCBA 2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE PUMP HAD AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) DUE TO SLIGHT CORROSION ON THE PCBA 1 AND PCBA 2. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.5 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. CUSTOMER ALLEGED FOR NO COMMUNICATION (SENSOR) ANOMALY WAS NOT CONFIRMED. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. HOWEVER, AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WAS CONFIRMED DUE TO SLIGHT CORROSION ON THE PCBA 1 AND PCBA 2. 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.
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. "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 EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER HAD A BLOOD GLUCOSE OF 30 MMOL/L. CUSTOMER'S MOTHER GOT REALLY UPSET AND SAID THE PUMP NEEDED TO BE REPLACED AND THEY WERE ADVISE OF THAT BY THEIR NURSE. THE CUSTOMER VISITED EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS NOT PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2109566 | PUMP MMT-1885A OUS BLE PUMP MMOL/L | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1885A | NG3420018H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Unknown | Required Intervention |