BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 13726559 · Received March 10, 2022

    Report

    Report Number
    2032227-2022-126565
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    October 10, 2021
    Report Date
    May 31, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    0000006431699997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. (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.

    Additional Manufacturer Narrative · 0

    S/W VERSION 2.9 D. RETAINER RING = CLEAR. CASE TYPE = NGP. CUSTOMER RETURNED PUMP FOR ALLEGED PUMP ERROR 63 FOUND ON (B)(6) 2021. THE PUMP PASSED THE DISPLACEMENT TEST AND SELF TEST. TEST P-CAP LOCKED PROPERLY INTO THE RESERVOIR COMPARTMENT, HOWEVER A CRACKED RETAINER RING WAS NOTED DURING VISUAL INSPECTION. NO PUMP ERROR 63 ALARM WAS NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED PUMP HISTORY FILES AND TRACES USING THUS SOFTWARE. PUMP ALARMED TWO PUMP ERROR 63 ALARMS (VARIABLE #: 3) ON THE EVENT DATE OF (B)(6) 2021 AT 07:50:57.000, AND 08:07:35.000 DUE TO BROKEN TRACES ON THE U1 CHIP AT THE KEYPAD ASSEMBLY ON PINS # 6 SDA AND #1 VDD. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND BROKEN TRACE ON THE U1 CHIP AT THE KEYPAD ASSEMBLY ON PINS # 6 SDA AND #1 VDD. MOISTURE DAMAGE WAS FOUND ISOLATED TO THE BATTERY TUBE. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: CORRODED BATTERY TUBE, CORRODED BATTERY TUBE SPRING, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, AND CRACKED RETAINER. PUMP ERROR 63 WAS CONFIRMED IN THE PUMP HISTORY FILES AND TRACES DUE TO BROKEN TRACES ON THE U1 CHIP AT THE KEYPAD ASSEMBLY ON PINS # 6 SDA AND #1 VDD. MOISTURE DAMAGE WAS CONFIRMED FOUND ISOLATED TO THE BATTERY TUBE. RETAINER RING DAMAGE WAS 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 PUMP ERROR 63 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
    658565 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG2YLW4 0000006431699997

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown