BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1712KL 640G V4.10 BK SF MG

    MDR report key: 12818601 · Received November 16, 2021

    Report

    Report Number
    2032227-2021-218733
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 19, 2021
    Report Date
    May 26, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DAT AT 0.0871 INCHES. NO DISPLACEMENT ANOMALY OR MOTOR ANOMALY NOTED DURING TESTING. THE MOTOR WAS TESTED OUTSIDE OF THE PUMP AND PASSED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED CASE AT CORNER OF THE BELT CLIP RAIL, AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. PLEASE SEE BELOW FOR THE BOLUSES LISTED ON THE EVENT DATE IN THE PUMP'S DOWNLOADED HISTORY FILE. 10/19/2021 01:34:41.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = (B)(4). BOLUSAMOUNTDELIVERED = (B)(4). 10/19/2021 08:23:36.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = (B)(4). BOLUSAMOUNTDELIVERED = (B)(4). 10/19/2021 08:23:41.000 ALARMALERTCLEARED FAULTNUMBER = RESERVOIR ESTIMATE 0 ALERT(113) 10/19/2021 08:47:14.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = (B)(4). BOLUSAMOUNTDELIVERED = (B)(4). 10/19/2021 14:28:16.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = (B)(4). BOLUSAMOUNTDELIVERED = (B)(4). 10/19/2021 21:48:50.000 NORMALBOLUSDELIVERED BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED = (B)(4). BOLUSAMOUNTDELIVERED = (B)(4). THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED LOW BG'S. THE CUSTOMER ALLEGED FOR POSSIBLE OVER DELIVERY ANOMALY WAS NOT CONFIRMED. DISPLACEMENT ANOMALY WAS NOT CONFIRMED. MOTOR ANOMALY WAS NOT CONFIRMED. 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

    IT WAS REPORTED THAT THE INSULIN PUMP WAS OVER DELIVERING. THE CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 67 MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 280 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER ALLEGING POSSIBLE INSULIN PUMP WAS OVER DELIVERY BECAUSE HE WAS GETTING TOO MUCH INSULIN WHILE IN AUTO MODE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1722387 PUMP MMT-1712KL 640G V4.10 BK SF MG PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712KL HG4E8ET

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown