BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 17057364 · Received June 5, 2023

    Report

    Report Number
    2032227-2023-212536
    Event Type
    Injury
    Date Received
    June 5, 2023
    Date of Event
    May 8, 2023
    Report Date
    July 2, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439866
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). RETAINER RING = BLACK. CASE TYPE = NGP. CUSTOMER RETURNED PUMP FOR AN ALLEGED POSSIBLE UNDER DELIVERY AND VISIT TO EMERGENCY ROOM FOR HIGH BGS FOUND ON (B)(6) 2023. ON (B)(4), SVN#: (B)(4) - CUSTOMER RETURNED PUMP FOR AN ALLEGED COSMETIC DAMAGE ON THE INFUSION SET, HIGH BGS AND DKA FOUND ON 16-AUG-2022. ON (B)(4), SVN#: (B)(4) - CUSTOMER RETURNED PUMP FOR AN ALLEGED AUTO MODE ANOMALY, SENSOR CALIBRATION ANOMALY AND HIGH BGS FOUND ON 02-AUG-2022. ON (B)(4), SVN#: (B)(4) - CUSTOMER RETURNED PUMP FOR AN ALLEGED SENSOR CALIBRATION NOT ACCEPTED AND CHANGE SENSOR ANOMALY FOUND ON (B)(6)2022. UNABLE TO CONFIRM COSMETIC DAMAGE ON THE INFUSION SET DUE TO PUMP RECEIVED WITHOUT THE ORIGINAL INFUSION SET. 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 (B)(4). 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 08-MAY-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 08-MAY-2023 LISTED ON SMARTSOLVE. DAILYTOTALOFALLINSULINDELIVERED: 479500 (47.95 U) DAILYTOTALOFBASALINSULINDELIVERED: 170500 (17.05 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 309000 (30.9 U) 05/08/2023 07:13:57.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1FOODBOLUS (7) NORMALBOLUSAMOUNTPROGRAMMED: 34000 (3.4 U) BOLUSAMOUNTDELIVERED: 34000 (3.4 U) 05/08/2023 11:34:47.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1BGCORRECTION (6) NORMALBOLUSAMOUNTPROGRAMMED: 10000 (1 U) BOLUSAMOUNTDELIVERED: 10000 (1 U) 05/08/2023 13:24:45.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1FOODBOLUS (7) NORMALBOLUSAMOUNTPROGRAMMED: 19000 (1.9 U) BOLUSAMOUNTDELIVERED: 19000 (1.9 U) 05/08/2023 14:05:09.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1FOODBOLUS (7) NORMALBOLUSAMOUNTPROGRAMMED: 30000 (3 U) BOLUSAMOUNTDELIVERED: 30000 (3 U) 05/08/2023 14:36:57.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 38000 (3.8 U) BOLUSAMOUNTDELIVERED: 38000 (3.8 U) 05/08/2023 15:59:57.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 63000 (6.3 U) BOLUSAMOUNTDELIVERED: 63000 (6.3 U) 05/08/2023 17:16:08.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 4000 (0.4 U) BOLUSAMOUNTDELIVERED: 4000 (0.4 U) 05/08/2023 17:31:47.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 8000 (0.8 U) BOLUSAMOUNTDELIVERED: 8000 (0.8 U) 05/08/2023 18:17:41.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 100000 (10 U) BOLUSAMOUNTDELIVERED: 100000 (10 U) 05/08/2023 23:10:54.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 3000 (0.3 U) BOLUSAMOUNTDELIVERED: 3000 (0.3 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. THE PUMP WAS PROGRAMMED WITH BASAL PROFILES AND MONITORED. ALL BASAL PROFILES DELIVERED THEIR INDICATED AMOUNTS AND WERE VERIFIED IN THE DAILY AND SUMMARY HISTORY SCREENS. THE PUMP WAS PROGRAMMED WITH A TEST GUARDIAN LINK (3) TRANSMITTER AND A 240 MG/DL GLUCOSE SENSOR SIMULATOR. THE PUMP WAS THEN PROGRAMMED FOR AUTO MODE. THE DISPLAY SHOWED THE CALIBRATE YOUR SENSOR ALARM PROPERLY AFTER COMPLETION OF THE AUTO MODE WARM UP. THE PUMP SENSOR FEATURE AND THE AUTO MODE CONNECTION ARE WORKING PROPERLY. NO SENSOR RELATED ERRORS OR ANOMALIES WERE NOTED. NO AUTO MODE ANOMALY, HISTORY ANOMALY, DELIVERY ANOMALY, BOLUS ANOMALY OR BASAL ANOMALY, UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED DURING TESTING. THERE WERE NO UNEXPECTED PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 08-MAY-2023 IN THE FORMATTED HISTORY FILE. 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 NOTED. NO POWER ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE ON THE EVENT DATE. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE ORIGINAL PCBA 2 WAS 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 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), SUSPECTED ON THE PCBA 1/PCBA 2. PLEASE SEE BELOW FOR THE DATE RANGE LISTED IN THE FORMATTED HISTORY FILE. THE FORMATTED HISTORY FILE LISTS DATA FROM 12/16/2022 TO 05/18/2023. THERE WAS NO DATA AVAILABLE TO VERIFY UNEXPECTED PUMP ERRORS/ALARMS 1 WEEK PRIOR TO THE EVENT DATES 16-AUG-2022, 02-AUG-2022 AND 14-JUL-2022 IN THE FORMATTED HISTORY FILE. 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. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY AND A SCRATCHED CASE. UNABLE TO CONFIRM COSMETIC DAMAGE ON THE INFUSION SET DUE TO PUMP RECEIVED WITHOUT THE ORIGINAL INFUSION SET. COSMETIC DAMAGE ON THE INFUSION SET WAS UNKNOWN. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS AND DKA. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. CUSTOMER ALLEGED FOR POSSIBLE UNDER DELIVERY WAS NOT CONFIRMED. AUTO MODE ANOMALY, SENSOR CALIBRATION ANOMALY, SENSOR CALIBRATION NOT ACCEPTED AND CHANGE SENSOR ANOMALY WERE NOT CONFIRMED. HOWEVER, AN INTERMITTENT HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WAS CONFIRMED, SUSPECTED ON THE PCBA 1/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.

    Additional Manufacturer Narrative · 0

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 540 MG/DL AT THE TIME OF HOSPITALIZATION. THE CURRENT BLOOD GLUCOSE VALUE WAS 327MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER REPORTED FLU-LIKE SYMPTOMS AT THE TIME OF HOSPITALIZATION. THE CUSTOMER WAS ALLEGING THE PUMP WAS UNDER-DELIVERING AS THE BLOOD SUGAR WENT UP WHEN THE SITE WAS CHANGED. IT WAS FOUND THAT THE CUSTOMER HAD TREATED THE HIGH BLOOD GLUCOSE EVENT WITH THE INSULIN PUMP, WENT TO THE EMERGENCY ROOM, AND TOOK AN IV INSULIN DRIP. THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. THE AUTO-MODE FEATURE WAS ACTIVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS UNKNOWN IF THE CUSTOMER WILL CONTINUE THE USE OF THE INSULIN PUMP. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244021 PUMP MMT-1880L MM770G BLE MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L HG5J6JK 000000763000439866

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention FRN-UNK-RSVR, UNOMED INF SET.