BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 12267176 · Received August 3, 2021

    Report

    Report Number
    2032227-2021-175741
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 20, 2021
    Report Date
    February 3, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169999763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = MISSING. CUSTOMER RETURNED INSULIN PUMP FOR AN ALLEGED BLANK DISPLAY FOUND ON (B)(6) 2021. THE INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. THE INSULIN PUMP PASSED THE SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST. THE INSULIN PUMP WAS MONITORED FOR SEVERAL HOURS AND NO BLANK DISPLAY NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE AND LOADED VOLTAGE WERE WITHIN SPECIFICATION RANGE. NO ALARMS OR ALERTS NOTED DURING THE TESTING. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 13:34:30.000 TO (B)(6) 2021 13:40:16.000 (B)(6) 2021 18:26:55.000 TO (B)(6) 2021 18:57:57.000. (B)(6) 2021 19:03:22.000 (B)(6) 202120:04:36.000 TO (B)(6) 2021 20:45:28.000 (B)(6) 2021 21:01:16.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 20:21:04.000 TO (B)(6) 2021 20:57:01.000 (B)(6) 202121:12:01.000 AND (B)(6) 2021 21:12:12.000 FAILED BATTERY/BATTERY FAILED ALARM (B)(6) 202113:34:44.000 AND (B)(6) 2021 13:34:46.000. UPON CHECKING ON THE DETAIL TRACE FILE, POWER LOSS ALARM AND FAILED BATTERY/BATTERY FAILED ALARM WAS EXPECTED SINCE THE BATTERY HAS LOW POWER. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND SLIGHT CORROSION ON THE ELECTRONIC ASSEMBLY. NO CORROSION OR MOISTURE DAMAGE FOUND ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. UNABLE TO PERFORM DISPLACEMENT TEST OR LOCK A TEST P-CAP INTO THE RESERVOIR COMPARTMENT DUE TO A MISSING RETAINER, A MISSING RESERVOIR TUBE O-RING AND A BROKEN RESERVOIR TUBE LIP. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A CRACKED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. A MISSING RESERVOIR TUBE O-RING, A BROKEN RESERVOIR TUBE LIP AND A MISSING RETAINER WAS CONFIRMED. BLANK DISPLAY NOT CONFIRMED. DURING VISUAL INSPECTION, FOUND SLIGHT CORROSION ON THE ELECTRONIC ASSEMBLY. 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. 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. 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 · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATED THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS AND DID NOT RETURN. CUSTOMER STATED DISPLAY WAS BLANK CURRENTLY. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP ARE NEITHER MISSING NOR DAMAGED. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THE SPRING WAS NEITHER DAMAGED NOR CORRODED. DISPLAY DID NOT RETURN AFTER INSULIN PUMP RESTART. 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
    1169214 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG20EUU 000000643169999763

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown