BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1711H

    MDR report key: 6867475 · Received September 14, 2017

    Report

    Report Number
    2032227-2017-48386
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    August 28, 2017
    Report Date
    May 9, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169739451
    Removal / Correction Number
    Z-0958-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. UPDATED H9: Z-0958-2020. 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. 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 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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, PRIME/SEATING TEST, BASIC OCCLUSION TEST AND FORCE SENSOR TEST. SLEEP CURRENT MEASUREMENT AND ACTIVE CURRENT MEASUREMENT WITHIN SPECIFICATIONS. NO UNEXPECTED BLANK DISPLAY ANOMALY NOTED. THE POWER MANAGEMENT TOOL CONFIRMED POWER ERROR DETECTED, AND LOW BATTERY ALERT WAS TRIGGERED WHEN THE BACKUP BATTERY LOADED VOLTAGE (LOADED VLITH) WAS LESS THAN 3.5V FOR 4 CONSECUTIVE HOURS DUE TO CONNECTOR RESISTANCE ELECTRICAL BOARD. AFTER DISCONNECTING AND RECONNECTING THE INTERNAL BATTERY CONNECTOR ON ELECTRICAL BOARD, THE PUMP WAS MONITORED AND FUNCTIONED PROPERLY. INSULIN PUMP PASSED THE DISPLACEMENT TEST. INSULIN PUMP RECEIVED WITH CRACKED RETAINER, CRACKED BATTERY TUBE THREADS, MISSING DISPLAY WINDOW COVER AND CRACKED CASE CORNER OF BELT CLIP RAILS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED A POWER SYSTEM ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 10 MMOL/L AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THE INTERNAL POWER SOURCE WAS UNABLE TO CHARGE, AND WOULD NOT RESPOND TO SEVERAL BATTERY CHANGES. CUSTOMER NOTED THE INSULIN PUMP DID NOT RECEIVE ANY KIND OF DAMAGE. DURING TROUBLESHOOTING, CUSTOMER WAS ADVISED TO TRY THE (B)(4) INDUSTRIAL BATTERIES. CUSTOMER NOTED IT DID NOT RESOLVE THE ISSUE. THE CUSTOMER WAS ADVISED A REPLACEMENT INSULIN PUMP WILL BE SENT OUT AND TO USE A BACKUP PLAN PER HEALTHCARE PROFESSIONAL'S RECOMMENDATION. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647530 640G INSULIN PUMP MMT-1711H PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711H HG159TN 00643169739451

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown