BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711K

    MDR report key: 10446944 · Received August 25, 2020

    Report

    Report Number
    2032227-2020-167613
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    August 14, 2020
    Report Date
    January 13, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000643169739468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020 THE CUSTOMER ALLEGED POWER LOSS ALARM. THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. DEVICE RECEIVED WITH PARTIALLY DETACHED RETAINER, CRACKED RETAINER, PILLOWING KEYPAD OVERLAY, CRACKED RESERVOIR TUBE LIP, CRACKED CASE ON CORNER OF BELT CLIP RAILS, CRACKED CASE ON BATTERY TUBE, CRACKED BATTERY TUBE THREADS AND FADED SERIAL NUMBER LABEL IDENTIFIED DURING THE VISUAL INSPECTION. THUS WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. IN FURTHER FULL REVIEW IN THE DEVICE HISTORY FOUND NO POWER LOSS ALARM ON THE EVENT DATE OF (B)(6)2020; HOWEVER, FOUND: LOW BATTERY ALARMS ON (B)(6) 2020. INSERT BATTERY ALARMS ON (B)(6)2020. ON (B)(6)2020,ON (B)(6)2020, ON (B)(6)2020, ON (B)(6)2020, ON (B)(6)2020, ON (B)(6)2020. FAILED BATTERY TEST ALARM ON (B)(6)2020, ON (B)(6)202017, ON (B)(6)2020. POWER LOSS ALARM ON (B)(6)2020. DEVICE PASSED SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND DISPLACEMENT TEST. NO UNEXPECTED LOW BATTERY, INSERT BATTERY, FAILED BATTERY TEST, AND POWER LOSS ALARMS DURING TESTING. IN SUMMARY, INSULIN PUMP PASSED REQUIRED TESTING. CUSTOMER ALLEGED FOR POWER LOSS ALARM WAS NOT CONFIRMED. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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

    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. (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.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD REPLACE BATTERY ALERT. THE CUSTOMER STATED THAT INSULIN PUMP WAS WORKING CORRECT. 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
    914230 640G INSULIN PUMP MMT-1711K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711K HG1PYST 000000643169739468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown