BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715K 630G BLACK MG

    MDR report key: 16144553 · Received January 12, 2023

    Report

    Report Number
    2032227-2023-104959
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    June 17, 2022
    Report Date
    January 12, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). S/W VERSION 4.11C. RETAINER RING = BLACK. CUSTOMER RETURNED PUMP FOR AN ALLEGED COSMETIC DAMAGE LOCATED AT THE BACK, NEAR THE BOTTOM OF THE CLIP RAILS AND UNEXPECTED ERRORS/ALARMS FOUND ON (B)(6) 2022. PUMP WAS RECEIVED WITH A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. THE PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DAT AT 0.08700 INCHES. THE PUMP WAS MONITORED FOR SEVERAL DAYS AND NO UNEXPECTED ERRORS/ALARMS NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF (B)(6) 2022, NO UNEXPECTED ERRORS/ALARMS NOTED. HOWEVER, NO DELIVERY AFTER ESTIMATE ZERO, NO RESERVOIR ALARM AND CHECK BOLUS BG ALERT WAS NOTED. NO DELIVERY AFTER ESTIMATE ZERO WAS RECORDED AND THE INSULIN DELIVERY STOPPED ON: 06/17/2022 02:19:00.000 06/17/2022 02:29:00.000 NO RESERVOIR ALARM WAS RECORDED AND THE INSULIN DELIVERY STOPPED ON: 06/17/2022 08:06:00.000 06/17/2022 08:16:00.000 AND CHECK BOLUS BG ALERT WAS RECORDED AND THE INSULIN DELIVERY CONTINUES ON: 06/17/2022 19:30:00.000. CHECK BOLUS BG ALERT WAS EXPECTED WHEN THE BG REMINDER DURATION ELAPSED. NO DELIVERY AFTER ESTIMATE ZERO WAS EXPECTED WHEN PRESSURE RESULTING FROM AN IMPROPERLY INSERTED RESERVOIR, A CLOGGED INFUSION SET OR THE END OF THE RESERVOIR DETECTED, AFTER THE ESTIMATE 0 ALERT WAS GIVEN. NO RESERVOIR ALARM WAS EXPECTED AS THE PUMP WENT ALL THE WAY TO THE END OF THE POSSIBLE DRIVE COUNTS WITHOUT DETECTING SEATING. THE USER PERFORMED REWIND ON: (B)(6) 2022 12:55:30.000 THE CANNULA TUBING FILL DELIVERED TUBING FILL ON: 06/17/2022 12:56:12.000 THE CANNULA TUBING FILL DELIVERED CANNULA FILL ON: 06/17/2022 12:56:14.000 THE USER SELECTS RESUMES (INSULIN DELIVERY RESTARTED) ON: 06/17/2022 12:56:14.000 PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATION (23.0 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A CRACKED KEYPAD OVERLAY, A PARTIALLY BROKEN BATTERY TUBE THREADS AND A SCRATCHED CASE. COSMETIC DAMAGE WAS CONFIRMED AT THE BACK, NEAR THE BOTTOM OF THE CLIP RAILS. THE PUMP PASSED ALL THE REQUIRED TESTING. UNEXPECTED ERRORS/ALARMS 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535053 630G INSULIN PUMP MMT-1715K 630G BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715K HG4HQJZ 000000763000316631

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown