BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1885L MM780G BLE MMOL

    MDR report key: 16172603 · Received January 16, 2023

    Report

    Report Number
    2032227-2023-118071
    Event Type
    Malfunction
    Date Received
    January 16, 2023
    Date of Event
    January 5, 2023
    Report Date
    April 18, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000521523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (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. 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 780G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A BLANK DISPLAY. UNABLE TO VERIFY FROZEN SCREEN AND PERFORM THE SELF TEST, ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT AND DISPLACEMENT TEST DUE TO BLANK DISPLAY. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES USING THUMP DUE TO BLANK DISPLAY. UNABLE TO GENERATE POWER MANAGEMENT GRAPH DUE TO BLANK DISPLAY. DURING VISUAL INSPECTION, CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT SHIFTED THE BATTERY TUBE OUT OF POSITION NOT ALLOWING PROPER CONTACT BETWEEN THE BATTERY CAP CONTACT AND BATTERY TUBE. THE PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE BATTERY TUBE ASSEMBLY WAS PUSHED BACK INTO THE RIGHT POSITION AND THE PUMP WAS ABLE TO POWER UP, CONTINUED SELF TEST, CURRENTS MEASUREMENT, DOWNLOAD OF HISTORY FILES AND TRACES USING THUMP. THE PUMP PASSED THE SELF TEST, SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT. THE PUMP WAS MONITORED, NO FROZEN SCREEN AND BLANK DISPLAY NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. 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 OR ALERTS NOTED. NO POWER ERROR 25, LOW BATTERY ALERT AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE ON THE EVENT DATE. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2023 20:46:52.000, (B)(6)2023 20:49:02.000, (B)(6)2023 20:49:08.000, (B)(6)2023 20:49:10.000 (B)(6)2023 20:55:17.000, 01/05/2023 20:56:32.000, 01/05/2023 20:56:38.000, 01/05/2023 20:57:04.000 01/05/2023 20:57:06.000, (B)(6)2023 20:57:10.000, (B)(6)2023 20:57:13.000, (B)(6)2023 20:58:12.000 (B)(6)2023 20:58:18.000, (B)(6)/2023 21:08:00.000, (B)(6)2023 21:55:29.000, (B)(6)2023 21:55:43.000 (B)(6)2023 21:57:35.000, (B)(6)/2023 21:58:07.000 FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2023 20:48:37.000, (B)(6)2023 20:49:03.000, (B)(6)2023 20:49:09.000, (B)(6)2023 20:54:59.000 (B)(6)/2023 20:55:10.000, (B)(6)2023 20:55:54.000, (B)(6)2023 20:56:35.000, (B)(6)2023 20:56:44.000 (B)(6)2023 20:56:56.000, (B)(6)2023 20:57:04.000, (B)(6)2023 20:57:08.000, (B)(6)2023 20:57:12.000 (B)(6)2023 20:57:53.000, (B)(6)2023 20:57:58.000, (B)(6)2023 20:58:16.000, (B)(6)2023 21:55:12.000 (B)(6)2023 21:55:34.000, (B)(6)2023 21:56:34.000, (B)(6)2023 21:56:44.000, (B)(6)2023 21:56:57.000 (B)(6)2023 21:57:02.000, (B)(6)2023 21:57:11.000, (B)(6)2023 21:57:24.000, (B)(6)2023 21:57:50.000 (B)(6)2023 21:58:01.000, (B)(6)2023 22:08:00.000 PUMP ERROR 68 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2023 22:09:05.000 PUMP ERROR 49 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2023 22:09:05.000 (B)(6)2023 22:09:20.000 PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2023 22:09:44.000 POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2023 22:10:23.000 (B)(6)2023 22:10:31.000 INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER OR DOES NOT HAVE ENOUGH POWER. THE CUSTOMER MAY HAVE USED A LOW/NO POWER/DEPLETED BATTERY. PUMP ERROR 68 ALARM, PUMP ERROR 49 ALARM, PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED DUE TO BATTERY BACKUP DEPLETION. BLANK DISPLAY WAS CONFIRMED DUE TO SHIFTED BATTERY TUBE ASSEMBLY. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6)2023 IN THE FORMATTED HISTORY FILE.  SENSOREXPIREDALERT (794) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2022 01:57:51.000 780 LOSTSENSOR1ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2022 18:00:00.000 781 LOSTSENSOR2ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2022 18:21:00.000 SENSORSIGNALNOTFOUND (796) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6)2023 09:03:00.000 (B)(6)2023 09:13:00.000 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 LOST SENSOR, SENSOR SIGNAL NOT FOUND, SENSOR EXPIRED ALERT OR UNEXPECTED SENSOR ERRORS OR ANOMALIES WERE NOTED DURING TESTING. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A PILLOWING KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. UNABLE TO VERIFY FROZEN SCREEN, PERFORM THE REQUIRED TESTING, DOWNLOAD HISTORY FILES AND TRACES USING THUMP DUE TO BLANK DISPLAY. BLANK DISPLAY WAS CONFIRMED DUE TO SHIFTED BATTERY TUBE ASSEMBLY. HOWEVER, THE BATTERY TUBE ASSEMBLY WAS PUSHED BACK INTO THE RIGHT POSITION AND THE PUMP WAS ABLE TO POWER UP, CONTINUED SELF TEST, CURRENTS MEASUREMENT, DOWNLOAD OF HISTORY FILES/TRACES USING THUMP AND NO FROZEN SCREEN/BLANK DISPLAY NOTED. 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 RECEIVED A CHANGE BATTERY ALARM AND THEN THE PUMP DID NOT WORK AGAIN DESPITE CHANGING THE BATTERY A NUMBER OF TIMES. THE CUSTOMER EXPERIENCED A SCREEN WHERE ALL ICONS WERE GREY AND THE PUMP DID NOT START AT ALL PAST THE MEDTRONIC LOGO. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER WAS CALLING BACK AFTER INSTALLING A NEW BATTERY, MONITORING THE PUMP FOR 2 HOURS AND FROZEN DISPLAY RECURRED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE DEVICE AND REVERT TO THE BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTIONS UNTIL THE REPLACEMENT PUMP ARRIVED. THE PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751562 PUMP MMT-1885L MM780G BLE MMOL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885L HG63D6S 000000763000521523

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown