BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12306799 · Received August 11, 2021

    Report

    Report Number
    2032227-2021-179371
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    August 1, 2021
    Report Date
    April 21, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000258344
    Removal / Correction Number
    Z-0958-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSULIN PUMP WAS RETURNED FOR A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM FOUND ON (B)(6), 2021. NO CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING BOOT UP. THE INSULIN 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 DELIVERY ACCURACY TEST AT 0.08695 INCHES. NO UNEXPECTED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOTED DURING THE TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. PER R&D ENGINEER, THERE WAS NO EVIDENCE OF THE OPEN-BOOK WAS FOUND IN THE BOOTLOADER TRACES. HOWEVER, PUMP ERROR 53 ALARM (LINENUMBER = 693 FILENUMBER = 51 ; LINENUMBER = 1384 FILENUMBER = 26) WERE RECORDED IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 11:20:50.000, (B)(6) 2021 11:26:13.000, (B)(6) 2021 11:36:00.000, (B)(6) 2021 11:39:49.000, PUMP ERROR 4 ALARM WAS RECORDED ON: (B)(6) 2021 11:26:11.000, PUMP ERROR 24 ALARM WAS RECORDED ON: (B)(6) /2021 11:16:00.000, (B)(6) 2021 11:24:00.000 AND (B)(6) 2021 11:32:00.000, PUMP ERROR 68 ALARM ON (B)(6) 2021 11:11:01.000, (B)(6) 2021 11:11:42.000, (B)(6) 2021 11:40:15.000 AND (B)(6) 2021 11:40:40.000, PUMP ERROR 49 ALARM FROM (B)(6) 2021 11:11:01.000 TO (B)(6) 2021 11:40:52.000 AND PUMP ERROR 23 ALARM FROM (B)(6) 2021 11:40:05.000 TO (B)(6) 2021 11:46:13.000. PUMP ERROR 53 ALARM, PUMP ERROR 4, 24, 68, 49 AND 23 ALARM WERE RECORDED IN THE FORMATTED HISTORY FILE, SUSPECTING THE HW. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE ELECTRONIC ASSEMBLY. CORROSION WAS ALSO FOUND ON THE BATTERY TUBE AND VIBRATOR ASSEMBLY NOTED. NO CORROSION OR MOISTURE DAMAGE ON THE FORCE SENSOR AND MOTOR ASSEMBLY NOTED. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT. HOWEVER, A CRACKED RETAINER¿WAS NOTED DURING TESTING. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE, A CRACKED KEYPAD OVERLAY, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT, A PILLOWING KEYPAD OVERLAY AND A SERIAL NUMBER LABEL FADING. A CRACKED RETAINER WAS CONFIRMED. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM NOT CONFIRMED. R&D ENGINEER, THERE WAS NO EVIDENCE OF THE OPEN-BOOK WAS FOUND IN THE BOOTLOADER TRACES. PUMP ERROR 53 ALARM, PUMP ERROR 4, 24, 68, 49 AND PUMP ERROR 23 ALARM WAS CONFIRMED, SUSPECTING THE HW. DURING VISUAL INSPECTION, FOUND CORROSION ON THE ELECTRONIC ASSEMBLY, BATTERY TUBE AND VIBRATOR ASSEMBLY NOTED. 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 REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. UPDATED H9: Z-0958-2020. 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 CRITICAL PUMP ERROR ALARM. 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
    1203247 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 HG3RDGH 000000763000258344

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown