BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 17947912 · Received October 17, 2023

    Report

    Report Number
    2032227-2023-284605
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    September 20, 2023
    Report Date
    October 17, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316655
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. THE PUMP PASSED THE FUNCTIONAL TESTS, 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 DAT AT 0.08700 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF (B)(6) 2023, THERE IS NO UNEXPECTED ALARMS/SUSPENDS. HOWEVER, NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS NOTED. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE (B)(6) 2023 LISTED ON SMARTSOLVE. DAILY TOTAL OF ALL INSULIN DELIVERED = 77.625. DAILY TOTAL OF BASAL INSULIN DELIVERED = 26.575. DAILY TOTAL OF BOLUS INSULIN DELIVERED = 51.05. (B)(6) 2023 05:11:04.000 NORMAL BOLUS DELIVERED BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 5. BOLUS AMOUNT DELIVERED = 1.85. (B)(6) 2023 06:14:56.000 NORMAL BOLUS DELIVERED BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 1.65. BOLUS AMOUNT DELIVERED = 0.2. (B)(6) 2023 06:23:28.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 1.65. BOLUS AMOUNT DELIVERED = 0.05. (B)(6) 2023 06:41:10.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 11.6. BOLUS AMOUNT DELIVERED = 3.55. (B)(6) 2023 06:41:36.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 1.65 BOLUS AMOUNT DELIVERED = 0.05. (B)(6) 2023 06:42:00.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 1.65. BOLUS AMOUNT DELIVERED = 0.05. (B)(6) 2023 06:46:14.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 1.65. BOLUS AMOUNT DELIVERED = 1.65. (B)(6) 2023 07:54:34.000 NORMAL BOLUS DELIVERED BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 10.925. BOLUS AMOUNT DELIVERED = 10.925. (B)(6) 2023 08:47:36.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 7.5. BOLUS AMOUNT DELIVERED = 7.5. (B)(6) 2023 12:35:36.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 24.65. BOLUS AMOUNT DELIVERED = 0.2. (B)(6) 2023 12:37:00.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 25. BOLUS AMOUNT DELIVERED = 0.05. (B)(6) 2023 12:44:37.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 4.4. BOLUS AMOUNT DELIVERED = 0. (B)(6) 2023 12:46:06.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 13.6. BOLUS AMOUNT DELIVERED = 1. (B)(6) 2023 13:15:28.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 4.6. BOLUS AMOUNT DELIVERED = 3.75. (B)(6) 2023 13:46:45.000 NORMAL BOLUS DELIVERED. SYSTEM TIME = (B)(6) 2023 13:46:45.000. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 10. BOLUS AMOUNT DELIVERED = 0.2. (B)(6) 2023 13:49:44.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 4. BOLUS AMOUNT DELIVERED = 4. (B)(6) 2023 15:00:14.000 NORMAL BOLUS DELIVERED. BOLUS PROGRAMMING METHOD = BOLUS WIZARD. NORMAL BOLUS AMOUNT PROGRAMMED = 16.025. BOLUS AMOUNT DELIVERED = 16.025. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM WAS FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 05:11:04.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 06:14:56.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 06:23:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 06:23:28.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 06:24:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 06:41:10.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 06:41:36.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 06:42:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 12:35:36.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 12:36:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 12:37:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 12:43:00.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BASAL DELIVERY. (B)(6) 2023 12:44:37.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 12:46:06.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 13:15:28.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. (B)(6) 2023 13:46:45.000 ALARM ALERT NOTIFICATION FAULT NUMBER = NO DELIVERY (7) DURING BOLUS DELIVERY. THE PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL BOLUS DELIVERED PROPERLY THEIR INDICATED AMOUNTS (AT QUICK BOLUS SPEED) AND WERE PROPERLY RECORDED IN THE DAILY HISTORY. NO BOLUS DELIVERY ANOMALY OR HISTORY ANOMALY NOTED. NO UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM NOTED DURING TESTING. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6) 2023 IN THE FORMATTED HISTORY FILE.  INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 16:33:40.000. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2023 14:46:00.000. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS/ALERTS WERE NOTED. NO POWER ERROR 25 ALARM, POWER LOSS ALARM AND REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM RECORDED IN THE FORMATTED HISTORY FILE ON THE EVENT DATE. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, LOW BATTERY ALERT WAS EXPECTED SINCE THE BATTERY IN THE PUMP IS LOW ON POWER. THE CUSTOMER MAY HAVE USED A LOW POWER/DEPLETED BATTERY. NO UNEXPECTED LOW BATTERY ALERT NOTED DURING TESTING. THE PUMP WAS RECEIVED WITH THE ORIGINAL BATTERY CAP. NO CRACKED/DAMAGED BATTERY CAP NOTED DURING VISUAL INSPECTION. THE PUMP WAS RECEIVED WITHOUT A BATTERY INSTALLED. THE TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE AND A SERIAL NUMBER LABEL FADING. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. NO DELIVERY ALARM/INSULIN FLOW BLOCKED ALARM 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 387 MG/DL. THE CUSTOMER REPORTED HEADACHE, DIABETIC KETOACIDOSIS, MALAISE. TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT INSULIN FLOW BLOCK ALERTS ON TWO INFUSION SETS ALSO CUSTOMER USED EMERGENCY MEDICAL SERVICES. IT WAS FOUND THAT THE CUSTOMER HAS TREATED THE HIGH BLOOD GLUCOSE EVENT WITH THE INSULIN PUMP. THE CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF THE REPORTED EVENT AND THE AUTO-MODE FEATURE WAS NOT ACTIVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL CONTINUE THE USE OF THE INSULIN PUMP AND THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025691 630G INSULIN PUMP MMT-1715KL 630G AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL NG3289815H 000000763000316655

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male Required Intervention FRN-MMT-332-RSVR, UNOMED INF SET