BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 16662267 · Received April 3, 2023

    Report

    Report Number
    2032227-2023-180184
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    March 9, 2023
    Report Date
    May 11, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316655
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    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 0.0873 INCHES. ALL BUTTONS FUNCTION PROPERLY. NO UNRESPONSIVE BUTTONS, BUTTON ERROR ALARM OR STUCK BUTTON ALARM NOTED. NO UNEXPECTED NUMBERS RAMPING OR SCROLL BAR MOVING UP OR DOWN WITH NO INPUT FROM THE USER NOTED. NO DAMAGE NOTED ON THE KEYPAD TRACES. THE PUMP PASSED THE KEYPAD VOLTAGE TEST. KEYPAD UNRESPONSIVE/STUCK BUTTON ALARM NOT CONFIRMED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: 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 WERE NO FAULTNUMBER: STUCKKEYALARM (61) NOTED IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6) 2023 IN THE PUMP HISTORY FILE. (B)(6) 2023 14:58:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOST SENSOR 1 ALERT (780), (B)(6) 202315:21:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOST SENSOR 2 ALERT (781) ,(B)(6) 2023 06:18:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOST SENSOR 1 ALERT (780), (B)(6) 2023 10:53:24.000 BATTERYREMOVED (B)(6) 202310:53:24.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84), (B)(6) 202310:53:48.000 BATTERYINSERTED (B)(6) 2023 10:53:48.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58), (B)(6) 2023 10:57:29.000 BATTERYREMOVED (B)(6) 2023 10:57:29.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84), (B)(6) 2023 10:57:30.000 BATTERYINSERTED (B)(6) 202310:57:30.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58), 03/09/2023 11:07:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = FAILED BATT TEST (58), (B)(6) 202312:05:27.000 BATTERYREMOVED (B)(6) 2023 12:05:27.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84), (B)(6) 2023 12:06:22.000 BATTERYINSERTED (B)(6) 2023 16:18:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOST SENSOR 1 ALERT (780), (B)(6) 202316:28:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOST SENSOR 1 ALERT (780), (B)(6) 2023 16:58:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOST SENSOR 2 ALERT (781), (B)(6) 202317:08:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = LOST SENSOR 2 ALERT (781) (B)(6) 2023 17:17:38.000 BATTERYREMOVED (B)(6) 2023 17:17:38.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84), (B)(6) 2023 17:18:02.000 BATTERYINSERTED FAILED BATT TEST (58) (NOT CONFIRMED) WAS DUE TO THE BATTERY INSERTED ON A BATTERY CHANGE DOES NOT HAVE SUFFICIENT VOLTAGE. THE TEST BATTERY WAS REMOVED AND REINSERTED WITH NO FAILED BATT TEST ALARM NOTED DURING TESTING. 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. THE PUMP PROPERLY PAIRED WITH THE GUARDIAN LINK TRANSMITTER. AFTER THE PUMP COMPLETED WARM UP AND CALIBRATION, THE PUMP WAS ABLE TO DISPLAY THE TEST BG VALUE OF 239 MG/DL ON THE PUMP'S HOME SCREEN. NO COMMUNICATION ANOMALY, CALIBRATION ANOMALY OR LOST SENSOR ALERT NOTED. LOST SENSOR 1 ALERT NOT CONFIRMED. FAILED BATT TEST (58) NOT CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED LOW BGS. KEYPAD UNRESPONSIVE/BUTTON ERROR ALARM/STUCK BUTTON ALARM 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. 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 CUSTOMER REPORTED HYPOGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 27 MG/DL. THE CUSTOMER WAS ADMITTED TO THE EMERGENCY ROOM TO TREAT HYPOGLYCEMIA. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP WAS DROPPED AND THE BUTTONS WERE STUCK. TROUBLESHOOTING WAS PERFORMED FOR KEYPAD ANOMALY AND THE CUSTOMER STATED THAT THE NUMBERS RAMPING AND THE SCROLL BAR MOVING WITHOUT INPUT. TROUBLESHOOTING WAS DECLINED FOR THE LOW BLOOD GLUCOSE. IT IS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED LOW BLOOD GLUCOSE EVENT. THE CUSTOMER WILL CONTACT THEIR HEALTHCARE PROFESSIONAL FOR FURTHER ASSISTANCE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102176 630G INSULIN PUMP MMT-1715KL 630G AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG6B4BZ 000000763000316655

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| R| O OZP-MMT-7020A-SNSR,FRN-MMT-332A-RSVR,UNOMED SET