BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1780KL 670G 3ML BLACK RPL

    MDR report key: 15435863 · Received September 16, 2022

    Report

    Report Number
    2032227-2022-337291
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    May 14, 2022
    Report Date
    September 16, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). RETAINER RING = BLACK. SN#: (B)(4). CUSTOMER RETURNED DEVICE FOR AN ALLEGED PUMP ERROR 25 ALARM FOUND ON MAY 14, 2022. THE DEVICE PASSED THE DISPLACEMENT TEST, SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT AND SELF TEST. THE DEVICE WAS MONITORED FOR SEVERAL HOURS, AND NO PUMP ERROR 25 ALARM NOTED DURING THE TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE DEVICE TRACE DOWNLOAD ANALYSIS CONFIRMED THE DEVICE ALARMED PUMP ERROR 25. NO LOW BATTERY ALERT, POWER LOSS ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE FOR THE EVENT DATE. HOWEVER, PUMP ERROR 25 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2022 02:00:00.000, 05/13/2022 02:45:00.000, 05/13/2022 12:00:00.000 (B)(6) 2022 12:10:00.000, 05/13/2022 16:00:00.000, 05/13/2022 16:10:00.000 (B)(6) 2022 11:00:00.000. THE POWER MANAGEMENT TOOL CONFIRMED PUMP ERROR 25 ALARM WAS TRIGGERED WHEN THE BACKUP BATTERY LOADED VOLTAGE (LOADED VLITH) WAS LESS THAN 3.5V FOR 4 CONSECUTIVE HOURS DUE TO CONNECTOR RESISTANCE ELECTRICAL BOARD. AFTER DISCONNECTING AND RECONNECTING THE INTERNAL BATTERY CONNECTOR ON ELECTRICAL BOARD, THE DEVICE WAS MONITORED AND FUNCTIONED PROPERLY. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRICAL BOARDS, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. PUMP ERROR 25 ALARM WAS CONFIRMED. PUMP ERROR 25 ALARM DUE TO CONNECTOR RESISTANCE ISSUE ON ELECTRICAL BOARD. 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 INSULIN PUMP HAD A POWER ERROR ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED THAT NOTIFICATION LIGHT STOP FLASHING IMMEDIATELY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125278 PUMP MMT-1780KL 670G 3ML BLACK RPL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. 1780KX HG4KQ2P

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female