BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 14520719 · Received May 27, 2022

    Report

    Report Number
    2032227-2022-195890
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    May 15, 2020
    Report Date
    May 27, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00763000192143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER RETURNED PUMP FOR AN ALLEGED BATTERY LASTING LESS THAN EXPECTED AND OVERHEATING DEVICE ON EVENT DATE (B)(6) 2020. THE INSULIN PUMP PASSED DISPLACEMENT TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT. PUMP FAILED VIBRATION SEGMENT OF SELF TEST DUE TO MOISTURE DAMAGE ON THE VIBRATION HARNESS ASSEMBLY. TEST P-CAP / RESERVOIR LOCKS PROPERLY INTO PLACE, HOWEVER, DAMAGE WAS NOTED TO THE RETAINER RING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. AN UNEXPECTED BATTERY POWER LOSS OCCURRED IN HISTORY TRACE FILE ON 05/12/2020 23:04:00.000 ["FAULT 6: ['05/12/2020 23:05:45.000', '05/12/2020 23:05:56.000']", "FAULT 104: ['05/12/2020 23:04:00.000']"]. THE INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND EVIDENCE OF MOISTURE DAMAGE ON PCB1 AND PCB2. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, KEYPAD OVERLAY TEXTURE DAMAGE, SCRATCHED CASE, DAMAGED DISPLAY WINDOW COVER, CRACKED CASE (BATTERY TUBE), CRACKED RETAINER, PARTIALLY DETACHED RETAINER AND CORRODED BATTERY TUBE. IN SUMMARY, CUSTOMER ALLEGATION FOR PUMP'S BATTERY LASTING LESS THAN 1 WEEK CONFIRMED IN THE PUMP/TRACE DOWNLOAD FILE DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLIES. FAILED SELF TEST DUE TO VIBRATION MOTOR ANOMALY CONFIRMED BY MOISTURE DAMAGE ON THE VIBRATION HARNESS ASSEMBLY. DEVICE HEATING UP NOT CONFIRMED. 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. 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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BATTERY OF THE INSULIN PUMP WAS EXHAUSTED IN 1 DAY. THE BATTERY LOCATION OF THE INSULIN PUMP HEATED UP TOO MUCH, WAS VIBRATING AND MAKING NOISE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USE OF THE DEVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237375 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K 00763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown