BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 17500167 · Received August 10, 2023

    Report

    Report Number
    2032227-2023-252942
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    July 21, 2023
    Report Date
    October 3, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000578640
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNABLE TO PERFORM THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT TEST, ACTIVE CURRENT MEASUREMENT TEST AND SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. NO FROZEN SCREEN WAS NOTED DURING TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND A CORRODED HOME SWITCH AND MOISTURE DAMAGE ON THE PCBA 1, PCBA 2, MOTOR, AND FORCE SENSOR. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. CRITICAL PUMP ERROR (OPEN BOOOK IMAGE) ALARM WAS CAUSED BY THE LCD TEST IN THE BOOTLOADER FAILED. PUMP ERROR 63 VARIABLE 15 WAS FOUND ON (B)(6) 2023 AT 11:33:00.00 DUE TO A TWO WIRE INTERFACE PROGRAMMING ERROR. PUMP ERROR 4 WAS CONFIRMED ON (B)(6) 2023 AT 11:33:07.00 DUE TO AN ERROR IN IPC COMMUNICATION IN MOTOR CPU. OCCURRED AS RESULT OF INTERRUPTED IPC COMMUNICATION BECAUSE MAIN CPU RESTARTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), CRACKED CASE - CORNER OF BELT CLIP RAILS, LABEL DAMAGE (FADED, STAINED). CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO AN LCD TEST HARDWARE ANOMALY. UNABLE TO DOWNLOAD CARELINK FILES CONFIRMED DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. UNABLE TO TEST FOR SELF TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. UNSPECIFIED COSMETIC DAMAGE CONFIRMED DURING ANALYSIS. PARTIAL DISPLAY WAS NOT OBSERVED DURING ANALYSIS. PARTIAL DISPLAY WAS NOT CONFIRMED. PUMP EXPOSED TO MOISTURE CONFIRMED AT PCBA 1, PCBA 2, MOTOR, AND FORCE SENSOR. UNABLE TO CONFIRM AUDIO ANOMALY DUE TO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. 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. 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 REPORTED THAT THE INSULIN PUMP WAS ALARMING. THE SCREEN WAS GRAY. AND THE PUMP HAD HIT THE WALL. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER STATED, THE LITTLE SCRATCHES. ASSISTED THE CUSTOMER IN RUNNING A SELF-TEST ON THE PUMP. AND THE PUMP DID NOT PASS THE TEST. THE CUSTOMER REPORTED, A PARTIAL DISPLAY AND THE PUMP WAS BUMPED, STRONG IMPACT LEADING UP TO THE EVENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE INSULIN PUMP USE. AND REVERT TO THE BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. AND THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761737 PUMP MMT-1880L MM770G BLE MG AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L NG3321873H 000000763000578640

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female