BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1711KL 640G V4.10 BK SF MM

    MDR report key: 13050510 · Received December 21, 2021

    Report

    Report Number
    2032227-2021-232790
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    December 13, 2021
    Report Date
    June 12, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. PUMP RETURNED WITH PUMP ERROR 3 AND PUMP ERROR 54 ON 13-DEC-2021. PUMP'S HISTORY AND TRACE FILES DOWNLOADED SUCCESSFULLY USING THUS SOFTWARE. PUMP PASSED THE SELF TEST AND DISPLACEMENT TEST. NO PUMP ERROR 54 AND PUMP ERROR 3 ALARMS NOTED DURING TESTING. FILLING CANNULA BY 0.2 U IS RECORDED IN THE DAILY HISTORY. PUMP ERROR 54 WAS PRESENT IN THE HISTORY DOWNLOAD ON EVENT DATE OF 12/12/2021 09:48 PM. ESF#: 3010978, (FILE NUMBER 32122 LINE NUMBER 1421). PUMP ERROR 3 WAS PRESENT ON EVENT DATE OF 12/12/2021 AT 09:48 PM. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. TEST P - CAP/ RESERVOIR LOCKS PROPERLY INTO PLACE. DURING VISUAL INSPECTION THE FOLLOWING WERE NOTED: PILLOWING KEYPAD OVERLAY, AND A SCRATCHED CASE. PUMP ERROR 3 CONFIRMED ON EVENT DATE OF 12/12/2021 AT 09:48 PM AND PUMP ERROR 54 (LINE NUMBER: 1421 , FILE NUMBER: 32122) ALARMS CONFIRMED IN PUMP HISTORY/TRACE FILES ON 12/12/2021 AT 09:48 PM DUE TO A SOFTWARE ANOMALY ESF#: 3010978. 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 · 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 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD REPEATED HAL SOFTWARE ERROR DETECTED ERROR ALARM AND HAD MAIN ARM CANNOT COMMUNICATE WITH THE MOTOR ARM ERROR ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND. FILL CANNULA WAS NOT RECORDED IN THE DAILY HISTORY. 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
    1948458 PUMP MMT-1711KL 640G V4.10 BK SF MM PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1711KL HG5FMRE 000000763000317119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown