BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782KL 670G MM RPL

    MDR report key: 12406352 · Received September 1, 2021

    Report

    Report Number
    2032227-2021-187209
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 23, 2021
    Report Date
    January 27, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER RETURNED PUMP FOR AN ALLEGED BLANK DISPLAY, CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND EXPOSURE TO MOISTURE FOUND ON AUG 23, 2021. NO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM¿NOTED DURING BOOT UP. NO BLANK DISPLAY NOTED. THE PUMP PASSED THE SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08710 INCHES. HOWEVER, THE PUMP HAD A HIGH ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. NO UNEXPECTED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING THE TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM, PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM (VARIABLEINFO = 15 & VARIABLEINFO = 09) WERE RECORDED AND FOUND IN THE FORMATTED HISTORY FILES ON 08/23/2021 19:38:01.000, 08/23/2021 23:06:17.000 AND 08/23/2021 23:16:00.000, SUSPECTED ON HW. 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 DURING THE TESTING. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/01/2021 14:04:30.000; 08/15/2021 13:18:53.000; 08/19/2021 10:08:25.000 TO 08/19/2021 10:11:38.000. FAILED BATT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/19/2021 10:08:42.000 TO 08/19/2021 10:09:51.000. AND POWER ERROR ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/23/2021 23:00:00.000 AND 08/24/2021 03:00:00.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. HOWEVER, CORROSION WAS FOUND ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE ORIGINAL PCB2 WAS INSTALLED IN A TEST PCB1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCB1 WAS INSTALLED IN A TEST PCB2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE PUMP HAD A HIGH ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT DUE TO CORROSION ON THE PCBA1 AND PCBA2. 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 BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. BLANK DISPLAY WAS NOT CONFIRMED. PUMP ERROR 25 ALARM AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WERE CONFIRMED. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS CONFIRMED DUE TO PUMP ERROR 4 AND PUMP ERROR 63 ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM, PUMP ERROR 4 ALARM, PUMP ERROR 63 ALARM, PUMP ERROR 25 ALARM AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WERE DUE TO CORROSION ON THE PCBA1 AND PCBA2. DURING VISUAL INSPECTION, CORROSION WAS ALSO FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. PUMP EXPOSED TO MOISTURE WAS 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.

    Additional Manufacturer Narrative · 0

    S.W VERSION 4.11J. RETAINER RING = BLACK. CUSTOMER RETURNED PUMP FOR AN ALLEGED BLANK DISPLAY, CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND EXPOSURE TO MOISTURE FOUND ON AUG 23, 2021. NO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING BOOT UP. NO BLANK DISPLAY NOTED. THE PUMP PASSED THE SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08710 INCHES. HOWEVER, THE PUMP HAD A HIGH ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. NO UNEXPECTED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING THE TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM, PUMP ERROR 4 ALARM AND PUMP ERROR 63 ALARM (VARIABLEINFO = 15 & VARIABLEINFO = 09) WERE RECORDED AND FOUND IN THE FORMATTED HISTORY FILES ON 08/23/2021 19:38:01.000, 08/23/2021 23:06:17.000 AND 08/23/2021 23:16:00.000, SUSPECTED ON HW. 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 DURING THE TESTING. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/01/2021 14:04:30.000; 08/15/2021 13:18:53.000; 08/19/2021 10:08:25.000 TO 08/19/2021 10:11:38.000. FAILED BATT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/19/2021 10:08:42.000 TO 08/19/2021 10:09:51.000. AND POWER ERROR ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 08/23/2021 23:00:00.000 AND 08/24/2021 03:00:00.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO J7/PCB1. HOWEVER, CORROSION WAS FOUND ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE ORIGINAL PCB2 WAS INSTALLED IN A TEST PCB1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCB1 WAS INSTALLED IN A TEST PCB2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. THE PUMP HAD A HIGH ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT DUE TO CORROSION ON THE PCBA1 AND PCBA2. 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 BEHIND THE PUMP NEAR THE BATTERY TUBE COMPARTMENT. BLANK DISPLAY WAS NOT CONFIRMED. PUMP ERROR 25 ALARM AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WERE CONFIRMED. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS CONFIRMED DUE TO PUMP ERROR 4 AND PUMP ERROR 63 ALARM. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM, PUMP ERROR 4 ALARM, PUMP ERROR 25 ALARM AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WERE DUE TO CORROSION ON THE PCBA1 AND PCBA2. PUMP ERROR 63 ALARM DUE TO ELECTRONIC STACK. DURING VISUAL INSPECTION, CORROSION WAS ALSO FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. PUMP EXPOSED TO MOISTURE WAS 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. THE INFORMATION THAT PROVIDED WITH THE INITIAL REPORT WAS INCORRECT. THE CORRECT INFORMATION HAS BEEN INCLUDED WITH THIS REPORT.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRITICAL PUMP ERROR ALARM AND ALSO THEY WENT FOR SWIMMING. CUSTOMER REPORTED THAT THEY RECEIVED THE OPEN BOOK IMAGE ON THE INSULIN PUMP SCREEN. CUSTOMER STATED THEY REPLACED THE INSULIN PUMPS BATTERY BUT THE INSULIN PUMP DID NOT RETURN TO POWER. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307855 PUMP MMT-1782KL 670G MM RPL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782KL HG4MBHM 000000763000365905

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown