BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MMT-712 PARADIGM INSULIN PUMP

    MDR report key: 12744073 · Received November 3, 2021

    Report

    Report Number
    2032227-2021-214159
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 24, 2021
    Report Date
    July 25, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    UDI-DI
    000000613994470898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    ON THE EVENT DATE 24-OCT-2021. CUSTOMER RETURNED PUMP FOR AN ALLEGED A33 ALARM. UNABLE TO PERFORM SELF TEST AND DISPLACEMENT TEST DUE TO NO BUTTON RESPONSE. DEVICE RECEIVED WITH NO BUTTON RESPONSE AT ESC, ACT, UP AND DOWN BUTTONS DUE TO FLATTENED ACT BUTTON DOME SWITCH (CREASED). UNABLE TO VERIFY A33 ALARM DUE TO NO BUTTON RESPONSE. UNABLE TO DOWNLOAD PUMP HISTORY FILE DUE TO LISTED S/N ON THE PUMP IS (B)(6) AND S/N ON THE ELECTRONICS IS (B)(6). TRY TO DOWNLOAD THE PUMP. DEVICE HISTORY SUCCESSFULLY DOWNLOADED. DEVICE WAS CUT/OPEN AND INSPECTED NO MOISTURE DAMAGE OR COMPONENT DAMAGE FOUND INSIDE THE PUMP. TESTED WITH A TEST P-CAP AND THE TEST P-CAP LOCKED IN PLACE PROPERLY. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS. CONFIRMED INTERMITTENT BUTTON RESPONSE DUE TO FLATTENED ACT BUTTON DOME SWITCH (CREASED). UNABLE TO VERIFY A33 ALARM. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD RECEIVED A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER REPORTED OTHER PUMP ERROR ALARM. 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
    1640296 MMT-712 PARADIGM INSULIN PUMP PUMP, INFUSION, INSULIN LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712WWB A9712WWBJ 000000613994470898

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown