BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 11840580 · Received May 18, 2021

    Report

    Report Number
    2032227-2021-146441
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 1, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000069001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UNABLE TO PERFORM DISPLACEMENT TEST DUE TO MISSING RETAINER RING. THE PUMP FAILED THE SELF TEST DUE TO APPEARANCE OF PUMP ERROR 63. THE PUMP PASSED THE SLEEP CURRENT TEST AND ACTIVE CURRENT TEST. NO BATTERY ALERTS, ALARMS, OR ANOMALIES WERE NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED PUMP HISTORY FILES AND TRACES USING THUS SOFTWARE. PUMP ALARMED A PUMP ERROR 63 ALARM (VARIABLE #: 3) DURING TESTING ON (B)(6) 2023 AT 12:29:42.000 DUE TO BROKEN TRACES ON THE U1 CHIP AT THE KEYPAD ASSEMBLY ON PINS # 6 SDA AND #1 VDD. PUMP ALARMED A REPLACE BATTERY ALERT ON (B)(6) 2021 AT 01:35:00.000. PUMP ALARMED A LOW BATTERY ALERT ON (B)(6) 2021 AT 16:04:00.000 AND WAS EXPECTED. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE FORCE SENSOR AND BROKEN TRACES ON THE U1 CHIP AT THE KEYPAD ASSEMBLY ON PINS # 6 SDA AND #1 VDD. THE FOLLOWING WERE ALSO NOTED DURING VISUAL INSPECTION: CORRODED BATTERY TUBE, CORRODED BATTERY TUBE SPRING, BATTERY TUBE THREADS - CRACKED, SCRATCHED CASE, CRACKED KEYPAD OVERLAY, MISSING DISPLAY WINDOW/COVER, STAINED KEYPAD OVERLAY, CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, PILLOWING KEYPAD OVERLAY, LABEL DAMAGE, CRACKED RETAINER, BROKEN RESERVOIR TUBE LIP, DETACHED RETAINER, AND MISSING O-RING (RESERVOIR TUBE). RETAINER RING DAMAGE WAS CONFIRMED, MISSING RETAINER RING WAS CONFIRMED. PUMP ERROR 63 WAS CONFIRMED DURING TESTING DUE TO BROKEN TRACES ON THE U1 CHIP AT THE KEYPAD ASSEMBLY ON PINS # 6 SDA AND #1 VDD. UNEXPECTED BATTERY POWER LOSS WAS NOT CONFIRMED. MOISTURE DAMAGE WAS CONFIRMED FOUND ON THE BATTERY TUBE AND THE FORCE SENSOR. 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. 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 · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED REPLACE BATTERY NOW ALARM. CUSTOMER STATED THAT THE INSULIN PUMP DID NOT HAD LOW BATTERY ALERT PRIOR TO REPLACE BATTERY ALERT. CUSTOMER STATED THAT THE BATTERY CAP WAS NOT LOOSE, CRACKED OR DAMAGED. CUSTOMER STATED THAT THIS WAS THE SECOND OCCURRENCE OF REPLACE BATTERY ALERT WITH LOW BATTERY WARNING. 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
    742673 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG2C6MM 000000763000069001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown