BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 17937680 · Received October 16, 2023

    Report

    Report Number
    2032227-2023-283763
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    September 14, 2023
    Report Date
    December 20, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000578640
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 0.08715 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 14-SEP-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 14-SEP-2023 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME: (B)(6) 2023 00:00:00.000. DAILYTOTALOFALLINSULINDELIVERED: 171750 (17.175 U). DAILYTOTALOFBASALINSULINDELIVERED: 108750 (10.875 U). DAILYTOTALOFBOLUSINSULINDELIVERED: 63000 (6.3 U). (B)(6) 2023 12:35:11.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: CL1FOODBOLUS (7). NORMALBOLUSAMOUNTPROGRAMMED: 14000 (1.4 U). BOLUSAMOUNTDELIVERED: 14000 (1.4 U). (B)(6) 2023 13:00:49.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: CL1FOODBOLUS (7) NORMALBOLUSAMOUNTPROGRAMMED: 10000 (1 U) BOLUSAMOUNTDELIVERED: 10000 (1 U) (B)(6) 2023 15:42:45.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: CL1BGCORRECTION (6). NORMALBOLUSAMOUNTPROGRAMMED: 10000 (1 U). BOLUSAMOUNTDELIVERED: 10000 (1 U). (B)(6) 2023 20:03:57.000 NORMALBOLUSDELIVERED (220). BOLUSPROGRAMMINGMETHOD: CL1FOODBOLUS (7). NORMALBOLUSAMOUNTPROGRAMMED: 29000 (2.9 U). BOLUSAMOUNTDELIVERED: 29000 (2.9 U).THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED DURING TESTING. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 14-SEP-2023 IN THE FORMATTED HISTORY FILE. SGCALIBRATIONERROR (776) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 04:21:30.000. (B)(6) 2023 03:59:09.000. SENSORERRORALERT (801) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 13:19:57.000 .(B)(6) 2023 13:49:58.000. (B)(6) 2023 14:24:57.000. 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 239 MG/DL PROPERLY ON THE DISPLAY GRAPH. NO SG CALIBRATION ERROR, SENSOR ERROR ALERT 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, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 09:37:31.000. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 2023 09:37:00.000. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON(B)(6)2023 AT 10:41:58 PM. THERE WAS NO POWER DATA AVAILABLE FOR THE DATE OF (B)(6) 2023. UNABLE TO CHECK POWER DATA FOR LOW BATTERY ALERT. NO UNEXPECTED LOW BATTERY ALERT NOTED DURING THE 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 FAILED 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. A HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WAS CONFIRMED DUE TO SLIGHT CORROSION ON THE PCBA 2. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.7 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE AND A CRACKED CASE BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. UNABLE TO VERIFY CUSTOMER ALLEGED FOR LOW BGS. THE FORCE SENSOR IS WITHIN SPECIFICATION AND THE MOTOR FUNCTIONING PROPERLY. CUSTOMER ALLEGED FOR POSSIBLE OVER DELIVERY ANOMALY WAS NOT CONFIRMED. HOWEVER, A HIGH SLEEP CURRENT MEASUREMENT (UNEXPECTED BATTERY POWER LOSS) WAS CONFIRMED DUE TO SLIGHT CORROSION ON THE PCBA 2. DURING VISUAL INSPECTION, SLIGHT CORROSION WAS ALSO FOUND ON THE PCBA 1. 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

    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. 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 REPORTED THE INSULIN PUMP WAS GIVING TOO MUCH INSULIN AND EXPERIENCED HYPOGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 92 MG/DL AT THE TIME OF THE EVENT. THE CUSTOMER WAS TREATED WITH THE GLUCAGON SHOT AND 1/2 BOTTLE OF APPLE JUICE. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS AND THE AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506952 PUMP MMT-1880L MM770G BLE MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L NG3419852H 000000763000578640

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention FRN-MMT-332A-RSVR, UNOMED SET