BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 12621718 · Received October 13, 2021

    Report

    Report Number
    2032227-2021-204504
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    October 8, 2021
    Report Date
    July 22, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000187422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE PUMP PASSED THE DISPLACEMENT TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST. THE PUMP WAS MONITORED FOR SEVERAL HOURS AND NO BLANK DISPLAY NOTED. PUMP MONITORED WITHOUT THE TEST ENERGIZER BATTERY INSIDE THE BATTERY COMPARTMENT AND REINSERTS IT BACK INTO THE BATTERY COMPARTMENT FOR LESS THAN 10 MINUTES AND NO UNEXPECTED PUMP ERROR 23 ALARM NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. 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 DURING TESTING. NO POWER ERROR 25, LOW BATTERY ALERT AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/08/2021 13:59:52.000, 10/08/2021 14:00:22.000, 10/08/2021 14:00:49.000, 10/08/2021 14:01:09.000 10/08/2021 14:11:00.000, 10/08/2021 14:13:25.000 AND 10/08/2021 14:13:34.000 FAILED BATT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/08/2021 14:00:05.000, 10/08/2021 14:00:41.000 AND 10/08/2021 14:01:09.000 AND POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 10/08/2021 14:13:53.000 PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON 10/08/2021 14:13:00.000. EARLIEST POWER DATA AVAILABLE PER THE POWER MANAGEMENT TOOL/DETAIL TRACE FILE IS ON FEB 11, 2022 AT 3:12:00 AM. THERE WAS NO POWER DATA AVAILABLE FOR THE EVENT DATE OF OCT 08, 2021. UNABLE TO CHECK POWER DATA FOR FAILED BATT/BATTERY FAILED ALARM AND POWER LOSS ALARM. 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 ELECTRONIC ASSEMBLY, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT. HOWEVER, A CRACKED RETAINER AND A CRACKED RESERVOIR TUBE LIP WERE NOTED DURING TESTING. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A SCRATCHED CASE, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A SERIAL NUMBER LABEL FADING. A CRACKED RETAINER AND A CRACKED RESERVOIR TUBE LIP WERE CONFIRMED. BLANK DISPLAY AND PUMP ERROR 23 ALARM WERE 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.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND THE DISPLAY DID NOT RETURN. THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS AND DID NOT RETURN. THE CONTACTS ON THE BATTERY CAP WERE NOT MISSING OR DAMAGED. THE BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED ALSO THE SPRING WAS NEITHER DAMAGED NOR CORRODED. THE DISPLAY DID NOT RETURN AFTER INSULIN PUMP RESTART. A PUMP ERROR OCCURRED. THEY WERE ABLE TO CLEAR ALARM AND COMPLETE PUMP REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526853 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG3AWZF 000000763000187422

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown