BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15471385 · Received September 23, 2022

    Report

    Report Number
    2032227-2022-341874
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    September 12, 2022
    Report Date
    December 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317195
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (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 NGP 640G INSULIN PUMP WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. RETAINER = BLACK THE INSULIN PUMP WAS RETURNED FOR POWER LOSS ALARM AND LOW BATTERY ALARM ON EVENT DATE (B)(6) 2022. DEVICE PASSED THE DISPLACEMENT TEST AND SELF-TEST. SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT WITHIN SPECIFICATIONS. THE HISTORY WAS DOWNLOAD SUCCESSFULLY USING THUS SOFTWARE. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. DETAILED TRACE ANALYSIS DID NOT CONFIRM CHARGE BATTERY ALARM WAS TRIGGERED. BACKUP BATTERY UNLOADED OR LOADED VOLTAGE (UL VLITH) DID NOT DROP BELOW 3.5VOLT FOR CONSECUTIVE 240 MINUTES. NO UNEXPECTED BATTERY ALARMS NOTED ON LONG TRACE HISTORY FILES RELATED TO EVENT DATE. DEVICE RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. A TEST BATTERY WAS INSTALLED AND REMOVED IN THE BATTERY TUBE WITH NO ANOMALIES NOTED. INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO MOISTURE DAMAGE ON THE ELECTRICAL BOARD / FORCE SENSOR / MOTOR. DEVICE RECEIVED WITH FADING SERIAL NUMBER LABEL. THE DEVICE P-CAP / TEST RESERVOIR LOCKS IN PLACE PROPERLY. DEVICE WAS NOT CONFIRMED FOR LOW BATTERY ALARM AND POWER LOSS ALARM NOTED. DEVICE PASSED ALL REQUIRED TESTING. 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 INSULIN PUMP HAD REPLACE BATTERY ALARM. THE CUSTOMER RECEIVED A LOW BATTERY ALERT PRIOR TO THE REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM. IYT WAS REPORTED THAT THIS WAS THE SECOND OCCURRENCE OF REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM IN LESS THAN 8 HOURS AFTER A LOW BATTERY WARNING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2793287 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 HG5J7QV 000000763000317195

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown