BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16302546 · Received February 6, 2023

    Report

    Report Number
    2032227-2023-143241
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Date of Event
    November 23, 2022
    Report Date
    May 31, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000317119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    S/W 4.11D. RETAINER RING = BLACK. CASE TYPE = NGP. THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BGS AND POSSIBLE UNDER DELIVERY ANOMALY ON 23-NOV-2022. 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 0.0876 INCHES. NO POSSIBLE UNDER DELIVERY ANOMALY NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, 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. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. THERE WAS NO AUTO SUSPEND ALARM NOTED IN THE PUMP HISTORY FILE. THERE WAS NO USER SUSPENDED ALARM NOTED ON THE EVENT DATE 23-NOV-2022 IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE BOLUSES DELIVERED ON THE EVENT DATE 23-NOV-2022 IN THE PUMP HISTORY FILE. 11/23/2022 01:29:00.000 NORMALBOLUSDELIVERED. BOLUSPROGRAMMINGMETHOD = MANUAL BOLUS. NORMALBOLUSAMOUNTPROGRAMMED = 5.2. BOLUSAMOUNTDELIVERED = 5.2. 11/23/2022 03:27:12.000 NORMALBOLUSDELIVERED. BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD. NORMALBOLUSAMOUNTPROGRAMMED = 5. BOLUSAMOUNTDELIVERED = 5. 11/23/2022 06:14:34.000 NORMALBOLUSDELIVERED. BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD. NORMALBOLUSAMOUNTPROGRAMMED = 4. BOLUSAMOUNTDELIVERED = 4. 11/23/2022 11:23:52.000 NORMALBOLUSDELIVERED. BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD. NORMALBOLUSAMOUNTPROGRAMMED = 8. BOLUSAMOUNTDELIVERED = 8. PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE 23-NOV-2022. 11/24/2022 00:00:00.000 DAILYTOTALS. DAILYTOTALCOLLECTIONSTARTTIME = 11/23/2022 00:00:00.000. DAILYTOTALOFALLINSULINDELIVERED = 29.975. DAILYTOTALOFBASALINSULINDELIVERED = 7.775. DAILYTOTALOFBOLUSINSULINDELIVERED = 22.2. PLEASE SEE BELOW FOR THE PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE 23-NOV-2022 IN THE PUMP HISTORY FILE. 11/22/2022 01:20:50.000 BATTERYREMOVED. 11/22/2022 01:20:50.000 ALARMALERTNOTIFICATION. FAULTNUMBER = BATTERY REMOVED (84). 11/22/2022 01:30:00.000 ALARMALERTNOTIFICATION. FAULTNUMBER = BATTERY REMOVED (84). 11/22/2022 05:18:50.000 ALARMALERTNOTIFICATION. FAULTNUMBER = BATT OUT LIMIT (6). BATT OUT LIMIT (6) WAS DUE TO THE BATTERY REMOVED FOR MORE THAN 10 MINUTES PUMP OR RESET DUE TO BATTERY BACKUP DEPLETION. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. NO PUMP ERROR 25, LOW BATTERY ALERT, POWER LOSS ALARM, REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM NOTED DURING TESTING. BATT OUT LIMIT (6) NOT CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS. POSSIBLE UNDER DELIVERY ANOMALY 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 NGP 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE NGP INSULIN PUMP, WHICH IS MARKETED IN THE UNITED STATES. 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 HAS UNDER DELIVERY AND HIGH BLOOD GLUCOSE. THE CUSTOMER HAD REPORTED A BLOOD GLUCOSE VALUE OF 22MMOL/L  WAS ADMITTED TO HOSPITAL AND TREATED WITH MANUAL INJECTION AND LENGTH OF HOSPITALIZATION: 24 HOURS AND CUSTOMER TEST FOR KETONES:. IT IS UNKNOWN IF THE CUSTOMER HAD CONTINUED USING THE DEVICE. THE INSULIN PUMP WILL  BE RETURNED FOR THE PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115632 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 HG63D6H 000000763000317119

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown