BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1712KL 640G V4.10 BK SF MG

    MDR report key: 12793574 · Received November 11, 2021

    Report

    Report Number
    2032227-2021-216950
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    November 5, 2021
    Report Date
    June 21, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000367046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED BLANK DISPLAY AND CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM FOUND ON NOVEMBER 05, 2021. INSULIN PUMP WAS RECEIVED WITH A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. NO BLANK DISPLAY NOTED. 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. SUCCESSFULLY UTILIZED CREST AND THUS TO DOWNLOAD HISTORY FILES, TRACES AND COMLINK3 FILES. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPECIFICATION RANGE. NO POWER ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM, 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: 11/05/2021 19:27:07.000 TO 11/05/2021 19:31:10.000 AND FAILED BATT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: 11/05/2021 19:29:09.000 TO 11/05/2021 19:31:09.000. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATT/BATTERY FAILED ALARM WAS EXPECTED SINCE THE BATTERY HAS LOW/NO POWER. THE CUSTOMER MAY HAVE USED A LOW/DEPLETED BATTERY. THE INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND IT WAS VERIFIED THAT THE BATTERY TUBE POWER CONNECTOR IS PROPERLY CONNECTED TO ELECTRICAL BOARD. CORROSION ON THE ELECTRICAL BOARD 1, ELECTRICAL BOARD 2 AND FORCE SENSOR. NO CORROSION OR MOISTURE DAMAGE ON THE MOTOR AND VIBRATOR ASSEMBLY NOTED. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND INSULIN PUMP ERROR 35 ALARM CONFIRMED IN THE FORMATTED HISTORY FILE ON 11/05/2021 19:23:00.000 AND 11/05/2021 19:33:00.000. PERFORM BRUSH CLEANING WITH THE ISOPROPYL ALCOHOL THE MOISTURE DAMAGE AREAS AND REINSTALLED THE ORIGINAL ELECTRONICS, CASE, INTERNAL BATTERY AND MOTOR. THE CRITICAL PUMP ERROR OCCURRED DURING TESTING. IN CONCLUSION, CRITICAL PUMP ERROR (OPEN BOOK) AND INSULIN PUMP ERROR 35 ALARM FOUND IN THE FORMATTED HISTORY FILE DUE TO CORROSION ON THE FORCE SENSOR. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. BLANK DISPLAY WAS NOT CONFIRMED. HOWEVER, CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM CONFIRMED DUE TO FATAL ALARM PUMP ERROR 35. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AND INSULIN PUMP ERROR 35 ALARM CONFIRMED DUE TO CORROSION ON THE FORCE SENSOR. DURING VISUAL INSPECTION, FOUND CORROSION ON THE ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2. 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

    (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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 0

    THE INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER STATED BATTERY WAS CHANGED MULTIPLE TIMES, BUT THE ISSUE WAS NOT RESOLVED. CONTACTS ON BATTERY CAP WERE NOT MISSING NOR DAMAGED. CUSTOMER STATED DISPLAY WAS NOT RETURN AFTER RESTART. INSULIN PUMP HAD CRITICAL PUMP ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690450 PUMP MMT-1712KL 640G V4.10 BK SF MG PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712KL HG4FBGS 000000763000367046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown