640G INSULIN PUMP MMT-1712K
Report
- Report Number
- 2032227-2021-192227
- Event Type
- Malfunction
- Date Received
- September 14, 2021
- Date of Event
- September 6, 2021
- Report Date
- October 10, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- UDI-DI
- 000000763000317140
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
- Health Professional
- N
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 0.0871 INCHES. POSSIBLE UNDER DELIVERY ANOMALY NOT CONFIRMED. THE PUMP WAS PROGRAMMED WITH MULTIPLE TEST BOLUSES USING THE BOLUS WIZARD FEATURE. ALL CALCULATED BOLUS IN THE BOLUS FIELD DELIVERED PROPERLY. NO BOLUS DELIVERY ANOMALY NOTED. PER (B)(6) ¿ R&D ENGINEER AS PER PUMP HISTORY, HERE ARE ALL BOLUS WIZARD EVENTS RECORDED FOR SEP. 6, 2021, AND THE CORRESPONDING BOLUS DELIVERY ( PLEASE SEE THE HIGHLIGHTED): (PLEASE SEE THE ATTACHED EMAIL TO REFERENCE HIGHLIGHTED PORTIONS.) #1: (B)(6) 2021 08:01:16.000 BOLUSWIZARDESTIMATE EVENTTYPE = 61 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 53 SYSTEMTIME = (B)(6) 2021 08:01:16.000 BGUNITS = MG/DL CARBUNITS = GRAMS INPUTBGVALUE = 135 FOODINPUT = 0 CURRENTINSULINSENSITIVITYFACTOR = 36 CURRENTCARBRATIO = 9.5 LOWBGTARGETRANGE = 90 HIGHBGTARGETRANGE = 110 CORRECTIONESTIMATE = 0.6 FOODESTIMATE = 0 ACTIVEINSULIN = 0 ACTIVEINSULINADJUSTMENT = 0 BOLUSWIZARDESTIMATE = 0.6 BOLUSPROGRAMMINGSTEP = 0.1U ESTIMATEMODIFIEDBYUSERFLAG = BOLUS WIZARD ESTIMATE WAS NOT MODIFIED BY THE USER FINALESTIMATE = 0.6 (B)(6) 2021 08:01:22.000 NORMALBOLUSDELIVERED EVENTTYPE = 220 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 26 SYSTEMTIME = (B)(6) 2021 08:01:22.000 BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD BOLUSNUMBER = 112 PRESETBOLUSNUMBER = 0 NORMALBOLUSAMOUNTPROGRAMMED = 0.6 BOLUSAMOUNTDELIVERED = 0.6 #2: (B)(6) 2021 10:15:40.000 BOLUSWIZARDESTIMATE EVENTTYPE = 61 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 53 SYSTEMTIME = (B)(6) 2021 10:15:40.000 BGUNITS = MG/DL CARBUNITS = GRAMS INPUTBGVALUE = 205 FOODINPUT = 45 CURRENTINSULINSENSITIVITYFACTOR = 36 CURRENTCARBRATIO = 9.5 LOWBGTARGETRANGE = 90 HIGHBGTARGETRANGE = 110 CORRECTIONESTIMATE = 2.6 FOODESTIMATE = 4.7 ACTIVEINSULIN = 0.3 ACTIVEINSULINADJUSTMENT = 0.3 BOLUSWIZARDESTIMATE = 7 BOLUSPROGRAMMINGSTEP = 0.1U ESTIMATEMODIFIEDBYUSERFLAG = BOLUS WIZARD ESTIMATE WAS NOT MODIFIED BY THE USER FINALESTIMATE = 7 (B)(6) 2021 10:15:43.000 DUALBOLUSPROGRAMMED EVENTTYPE = 23 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 28 SYSTEMTIME = (B)(6) 2021 10:15:43.000 BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD BOLUSNUMBER = 113 PRESETBOLUSNUMBER = 0 NORMALBOLUSAMOUNTPROGRAMMED = 4.6 SQUAREBOLUSAMOUNTPROGRAMMED = 2.4 SQUAREWAVEBOLUSDURATION = 30 (B)(6) 2021 10:15:56.000 ALARMALERTNOTIFICATION EVENTTYPE = 40 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 29 SYSTEMTIME = (B)(6) 2021 10:15:56.000 FAULTNUMBER = NO DELIVERY (7) OCCLUSION ALARM LINENUMBER = 402 FILENUMBER = 121 NOTIFICATIONTYPE = TONE AND VIBRATION INSULINDELIVERYSTATE = INSULIN DELIVERY STOPPED EXTRADATAFLAG = NO EXTRA DATA CONTAINED IN BYTES 19-28 ALARMHISTORYSCREENFLAG = FAULT DISPLAYS IN ALARM HISTORY SCREEN NOTIFICATIONSCREENFLAG = FAULT DISPLAYS IN NOTIFICATION SCREEN VARIABLEINFO = 00 00 00 00 00 00 00 00 00 08 (B)(6) 2021 10:15:56.000 BOLUSCANCELED BOLUS WAS STOPPED DUE TO OCCLUSION EVENTTYPE = 39 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 14 SYSTEMTIME = (B)(6) 2021 10:15:56.000 CANCELLATIONREASON = ALARM BOLUSNUMBER = 113 BOLUSTYPE = NORMAL PART OF A DUAL BOLUS (B)(6) 2021 10:15:56.000 DUALBOLUSPARTDELIVERED EVENTTYPE = 222 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 35 SYSTEMTIME = (B)(6) 2021 10:15:56.000 BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD BOLUSNUMBER = 113 PRESETBOLUSNUMBER = 0 NORMALBOLUSAMOUNTPROGRAMMED = 4.6 SQUAREBOLUSAMOUNTPROGRAMMED = 2.4 BOLUSAMOUNTDELIVERED = 2.9 BOLUS DELIVERED DUALBOLUSPART = NORMAL PART OF A DUAL BOLUS SQUAREWAVEBOLUSPROGRAMMEDDURATION = 30 SQUAREWAVEBOLUSDELIVEREDDURATION = 0 ACTIVEINSULINATPROGRAMMINGTIME = 0.3 (B)(6) 2021 10:15:56.000 DUALBOLUSPARTDELIVERED EVENTTYPE = 222 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 35 SYSTEMTIME = (B)(6) 2021 10:15:56.000 BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD BOLUSNUMBER = 113 PRESETBOLUSNUMBER = 0 NORMALBOLUSAMOUNTPROGRAMMED = 4.6 SQUAREBOLUSAMOUNTPROGRAMMED = 2.4 BOLUSAMOUNTDELIVERED = 0 DUALBOLUSPART = SQUARE PART OF A DUAL BOLUS SQUAREWAVEBOLUSPROGRAMMEDDURATION = 30 SQUAREWAVEBOLUSDELIVEREDDURATION = 0 ACTIVEINSULINATPROGRAMMINGTIME = 0.3 TOTAL AMOUNT OF BOLUS DELIVERED =2.9+0= 2.9U #3: (B)(6) 2021 12:35:57.000 BOLUSWIZARDESTIMATE EVENTTYPE = 61 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 53 SYSTEMTIME = (B)(6) 2021 12:35:57.000 BGUNITS = MG/DL CARBUNITS = GRAMS INPUTBGVALUE = 304 FOODINPUT = 20 CURRENTINSULINSENSITIVITYFACTOR = 36 CURRENTCARBRATIO = 9 LOWBGTARGETRANGE = 90 HIGHBGTARGETRANGE = 110 CORRECTIONESTIMATE = 5.3 FOODESTIMATE = 2.2 ACTIVEINSULIN = 0.9 ACTIVEINSULINADJUSTMENT = 0.9 BOLUSWIZARDESTIMATE = 6.6 BOLUSPROGRAMMINGSTEP = 0.1U ESTIMATEMODIFIEDBYUSERFLAG = BOLUS WIZARD ESTIMATE WAS NOT MODIFIED BY THE USER FINALESTIMATE = 6.6 (B)(6) 2021 12:36:06.000 DUALBOLUSPROGRAMMED EVENTTYPE = 23 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 28 SYSTEMTIME = (B)(6) 2021 12:36:06.000 BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD BOLUSNUMBER = 114 PRESETBOLUSNUMBER = 0 NORMALBOLUSAMOUNTPROGRAMMED = 5.5 SQUAREBOLUSAMOUNTPROGRAMMED = 1.1 SQUAREWAVEBOLUSDURATION = 30 ACTIVEINSULIN = 0.9 (B)(6) 2021 12:36:29.000 DUALBOLUSPARTDELIVERED EVENTTYPE = 222 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 35 SYSTEMTIME = (B)(6) 2021 12:36:29.000 BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD BOLUSNUMBER = 114 PRESETBOLUSNUMBER = 0 NORMALBOLUSAMOUNTPROGRAMMED = 5.5 SQUAREBOLUSAMOUNTPROGRAMMED = 1.1 BOLUSAMOUNTDELIVERED = 5.5 DUALBOLUSPART = NORMAL PART OF A DUAL BOLUS SQUAREWAVEBOLUSPROGRAMMEDDURATION = 30 SQUAREWAVEBOLUSDELIVEREDDURATION = 0 ACTIVEINSULINATPROGRAMMINGTIME = 0.9 (B)(6) 2021 13:06:00.000 DUALBOLUSPARTDELIVERED EVENTTYPE = 222 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 35 SYSTEMTIME = (B)(6) 2021 13:06:00.000 BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD BOLUSNUMBER = 114 PRESETBOLUSNUMBER = 0 NORMALBOLUSAMOUNTPROGRAMMED = 5.5 SQUAREBOLUSAMOUNTPROGRAMMED = 1.1 BOLUSAMOUNTDELIVERED = 1.1 DUALBOLUSPART = SQUARE PART OF A DUAL BOLUS SQUAREWAVEBOLUSPROGRAMMEDDURATION = 30 SQUAREWAVEBOLUSDELIVEREDDURATION = 30 ACTIVEINSULINATPROGRAMMINGTIME = 0.9 TOTAL AMOUNT OF BOLUS DELIVERED = 5.5+1.1=6.6U #4: (B)(6) 2021 17:59:03.000 BOLUSWIZARDESTIMATE EVENTTYPE = 61 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 53 SYSTEMTIME = (B)(6) 2021 17:59:03.000 BGUNITS = MG/DL CARBUNITS = GRAMS INPUTBGVALUE = 142 FOODINPUT = 50 CURRENTINSULINSENSITIVITYFACTOR = 36 CURRENTCARBRATIO = 9 LOWBGTARGETRANGE = 90 HIGHBGTARGETRANGE = 110 CORRECTIONESTIMATE = 0.8 FOODESTIMATE = 5.5 ACTIVEINSULIN = 0 ACTIVEINSULINADJUSTMENT = 0 BOLUSWIZARDESTIMATE = 6.3 BOLUSPROGRAMMINGSTEP = 0.1U ESTIMATEMODIFIEDBYUSERFLAG = BOLUS WIZARD ESTIMATE WAS NOT MODIFIED BY THE USER FINALESTIMATE = 6.3 (B)(6) 2021 17:59:05.000 DUALBOLUSPROGRAMMED EVENTTYPE = 23 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 28 SYSTEMTIME = (B)(6) 2021 17:59:05.000 BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD BOLUSNUMBER = 115 PRESETBOLUSNUMBER = 0 NORMALBOLUSAMOUNTPROGRAMMED = 3.5 SQUAREBOLUSAMOUNTPROGRAMMED = 2.8 SQUAREWAVEBOLUSDURATION = 30 ACTIVEINSULIN = 0 (B)(6) 2021 17:59:21.000 DUALBOLUSPARTDELIVERED EVENTTYPE = 222 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 35 SYSTEMTIME = (B)(6) 2021 17:59:21.000 BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD BOLUSNUMBER = 115 PRESETBOLUSNUMBER = 0 NORMALBOLUSAMOUNTPROGRAMMED = 3.5 SQUAREBOLUSAMOUNTPROGRAMMED = 2.8 BOLUSAMOUNTDELIVERED = 3.5 DUALBOLUSPART = NORMAL PART OF A DUAL BOLUS SQUAREWAVEBOLUSPROGRAMMEDDURATION = 30 SQUAREWAVEBOLUSDELIVEREDDURATION = 0 ACTIVEINSULINATPROGRAMMINGTIME = 0 (B)(6) 2021 18:29:00.000 DUALBOLUSPARTDELIVERED EVENTTYPE = 222 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 35 SYSTEMTIME = (B)(6) 2021 18:29:00.000 BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD BOLUSNUMBER = 115 PRESETBOLUSNUMBER = 0 NORMALBOLUSAMOUNTPROGRAMMED = 3.5 SQUAREBOLUSAMOUNTPROGRAMMED = 2.8 BOLUSAMOUNTDELIVERED = 2.8 DUALBOLUSPART = SQUARE PART OF A DUAL BOLUS SQUAREWAVEBOLUSPROGRAMMEDDURATION = 30 SQUAREWAVEBOLUSDELIVEREDDURATION = 30 ACTIVEINSULINATPROGRAMMINGTIME = 0 TOTAL AMOUNT OF BOLUS DELIVERED = 3.5+2.8=6.3U AS PER DAILYTOTAL: (B)(6) 2021 00:00:00.000 DAILYTOTALS EVENTTYPE = 60 SOURCEID = PUMP (NGP IS IN OPEN LOOP STATE) HISTORYRECORDLENGTH = 108 SYSTEMTIME = (B)(6) 2021 00:00:00.000 DAILYTOTALCOLLECTIONSTARTTIME = 09/06/2021 00:00:00.000 DURATION = 1440 NUMBEROFMETERBG = 0 AVERAGEMETERBG = 0 LOWMETERBG = 0 HIGHMETERBG = 0 NUMBEROFMANUALLYENTEREDBG = 5 AVERAGEMANUALLYENTEREDBG = 188 LOWMANUALLYENTEREDBG = 135 HIGHMANUALLYENTEREDBG = 304 AVERAGEOFALLBG = 188 DAILYTOTALOFALLINSULINDELIVERED = 36.05 DAILYTOTALOFBASALINSULINDELIVERED = 19.65 PERCENTAGEOFDAILYTOTALDELIVEREDASBASALINSULIN = 55 DAILYTOTALOFBOLUSINSULINDELIVERED = 16.4 PERCENTAGEOFDAILYTOTALDELIVEREDASBOLUSINSULIN = 45 CARBOHYDRATEUNITS = GRAMS FOODINPUT = 115 TOTAL AMOUNT OF BOLUSES DELIVERED: 0.6+2.9+6.6+6.3=16.4U CONCLUSION: ON (B)(6) 2021, ALL PROGRAMMED BOLUSES EXCEPT FOR ONE WERE SUCCESSFULLY DELIVERED. ONE BOLUS WAS PARTIALLY DELIVERED DUE TO OCCLUSION (THE CORRESPONDING ALARM WAS GENERATED). THE PUMP BEHAVED AS EXPECTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, 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. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. PLEASE SEE THE BOLUSES DELIVERED ON THE EVENT DATE 06-SEP-2021 IN THE PUMP HISTORY FILE. (B)(6) 2021 08:01:22.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 0.6 BOLUSAMOUNTDELIVERED = 0.6 (B)(6) 2021 10:15:56.000 DUALBOLUSPARTDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 4.6 SQUAREBOLUSAMOUNTPROGRAMMED = 2.4 BOLUSAMOUNTDELIVERED = 2.9 DUALBOLUSPART = NORMAL PART OF A DUAL BOLUS SQUAREWAVEBOLUSPROGRAMMEDDURATION = 30 SQUAREWAVEBOLUSDELIVEREDDURATION = 0 ACTIVEINSULINATPROGRAMMINGTIME = 0.3 (B)(6) 2021 10:15:56.000 DUALBOLUSPARTDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 4.6 SQUAREBOLUSAMOUNTPROGRAMMED = 2.4 BOLUSAMOUNTDELIVERED = 0 DUALBOLUSPART = SQUARE PART OF A DUAL BOLUS SQUAREWAVEBOLUSPROGRAMMEDDURATION = 30 SQUAREWAVEBOLUSDELIVEREDDURATION = 0 ACTIVEINSULINATPROGRAMMINGTIME = 0.3 (B)(6) 2021 10:15:56.000 INSULINDELIVERYSTOPPED SYSTEMTIME = 09/06/2021 10:15:56.000 REASONFORINSULINDELIVERYSUSPENSION = ALARM SUSPENDED (B)(6) 2021 12:36:29.000 DUALBOLUSPARTDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 5.5 SQUAREBOLUSAMOUNTPROGRAMMED = 1.1 BOLUSAMOUNTDELIVERED = 5.5 DUALBOLUSPART = NORMAL PART OF A DUAL BOLUS SQUAREWAVEBOLUSPROGRAMMEDDURATION = 30 SQUAREWAVEBOLUSDELIVEREDDURATION = 0 ACTIVEINSULINATPROGRAMMINGTIME = 0.9 (B)(6) 2021 13:06:00.000 DUALBOLUSPARTDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 5.5 SQUAREBOLUSAMOUNTPROGRAMMED = 1.1 BOLUSAMOUNTDELIVERED = 1.1 DUALBOLUSPART = SQUARE PART OF A DUAL BOLUS SQUAREWAVEBOLUSPROGRAMMEDDURATION = 30 SQUAREWAVEBOLUSDELIVEREDDURATION = 30 ACTIVEINSULINATPROGRAMMINGTIME = 0.9 (B)(6) 2021 17:59:21.000 DUALBOLUSPARTDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 3.5 SQUAREBOLUSAMOUNTPROGRAMMED = 2.8 BOLUSAMOUNTDELIVERED = 3.5 DUALBOLUSPART = NORMAL PART OF A DUAL BOLUS SQUAREWAVEBOLUSPROGRAMMEDDURATION = 30 SQUAREWAVEBOLUSDELIVEREDDURATION = 0 ACTIVEINSULINATPROGRAMMINGTIME = 0 (B)(6) 2021 18:29:00.000 DUALBOLUSPARTDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = 3.5 SQUAREBOLUSAMOUNTPROGRAMMED = 2.8 BOLUSAMOUNTDELIVERED = 2.8 DUALBOLUSPART = SQUARE PART OF A DUAL BOLUS SQUAREWAVEBOLUSPROGRAMMEDDURATION = 30 SQUAREWAVEBOLUSDELIVEREDDURATION = 30 ACTIVEINSULINATPROGRAMMINGTIME = 0 PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON (B)(6) 2021. (B)(6) 2021 00:00:00.000 DAILYTOTALS DAILYTOTALCOLLECTIONSTARTTIME = (B)(6) 2021 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED = 36.05 DAILYTOTALOFBASALINSULINDELIVERED = 19.65 DAILYTOTALOFBOLUSINSULINDELIVERED = 16.4 THERE WERE NO AUTO SUSPEND (12) ALARM NOTED IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE USER SUSPENDED ALARM NOTED ON THE EVENT DATE 06-SEP-2021 IN THE PUMP HISTORY FILE. (B)(6) 2021 11:12:25.000 INSULINDELIVERYSTOPPED SYSTEMTIME = (B)(6) 2021 11:12:25.000 REASONFORINSULINDELIVERYSUSPENSION = USER SUSPENDED PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 06-SEP-2021 IN THE PUMP HISTORY FILE. (B)(6) 2021 09:25:48.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS (B)(6) 2021 10:04:01.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS (B)(6) 2021 14:01:24.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS (B)(6) 2021 17:50:02.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS (B)(6) 2021 20:17:32.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS (B)(6) 2021 23:04:20.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS (B)(6) 2021 03:33:58.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS (B)(6) 2021 04:35:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOW BATTERY ALERT (104) (B)(6) 2021 07:55:16.000 BATTERYREMOVED (B)(6) 2021 07:55:16.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2021 07:55:32.000 BATTERYINSERTED (B)(6) 2021 18:02:56.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS (B)(6) 2021 18:03:34.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS (B)(6) 2021 10:15:56.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY (7) - DURING BOLUS EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON (B)(6) 2022 12:32:00 AM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF (B)(6) 2021. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. HOWEVER, THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. NO PUMP ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM, REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM NOTED DURING TESTING. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. NO DELIVERY (7) NOT CONFIRMED. LOW BATTERY ALERT (104) UNKNOWN. THE PUMP PASSED THE FUNCTIONAL TESTING. POSSIBLE UNDER DELIVERY ANOMALY 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. INFORMATION HAS BEEN CORRECTED WHICH WAS NOT CORRECT IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTION B5 WITH THIS REPORT.
THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
(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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.
INFORMATION RECEIVED BY MEDTRONIC INDICATED THE INSULIN PUMP WAS NOT SENDING THE FULL BOLUS AMOUNT BUT A PARTIAL BOLUS. INSULIN PUMP DID NOT MAKE CORRECT CALCULATIONS BASED ON INFORMATION ENTERED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1369093 | 640G INSULIN PUMP MMT-1712K | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-1712K | HG4JJBT | 000000763000317140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |