BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 6860075 · Received September 12, 2017

    Report

    Report Number
    2032227-2017-47312
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    August 24, 2017
    Report Date
    May 9, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169662612
    Removal / Correction Number
    Z-0958-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PATIENT
    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

    DEVICE RECEIVED WITH CRITICAL PUMP ERROR DUE TO MOISTURE DAMAGE ELECTRONICS. UNABLE TO PERFORMED DOWNLOAD DUE TO MOISTURE DAMAGE. UNABLE TO PERFORMED DISPLACEMENT TEST, REWIND TEST, PRIME AND SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST DUE TO CRITICAL PUMP ERROR. DEVICE RECEIVED WITH MOISTURE DAMAGE NOTED ON MOTOR, VIBRATOR MOTOR OR BATTERY TUBE ASSEMBLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP HAD CRITICAL PUMP ERRORS ALARM. CUSTOMER BLOOD GLUCOSE READING WAS 154 MG/DL. CUSTOMER WAS AT BEACH BUT THE ISSUE OCCURRED AFTER THE BEACH. CUSTOMER WAS USING PEN AS A BACKUP. INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637514 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG12FE6 00643169662612

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown