BEUDAMED
    FDA Adverse Event Injury Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 17467563 · Received August 7, 2023

    Report

    Report Number
    2032227-2023-249421
    Event Type
    Injury
    Date Received
    August 7, 2023
    Date of Event
    June 1, 2023
    Report Date
    September 3, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000316655
    PMA / PMN Number
    P150001
    Removal / Correction Number
    2032227-060322-002-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    USING A TEST BATTERY CAP, 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. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. USING A TEST BATTERY CAP, THE PUMP WAS PROGRAMMED AND MONITORED FOR 5 DAYS. NO BLANK DISPLAY NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE BATTERY TUBE SIDE, PILLOWING KEYPAD OVERLAY, AND STAINED 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. THE PUMP WAS RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. UNABLE TO VERIFY BATTERY CAP DAMAGE. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE 01-JUN-2023 IN THE PUMP HISTORY FILE. (B)(6) 2023 06:34:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY AFTER ESTIMATE ZERO (8) - DURING BASAL (B)(6) 2023 06:44:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = NO DELIVERY AFTER ESTIMATE ZERO (8) - DURING BASAL (B)(6) 2023 19:42:28.000 BATTERYREMOVED (B)(6) 2023 19:42:28.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 19:42:39.000 BATTERYINSERTED (B)(6) 2023 19:43:30.000 BATTERYREMOVED (B)(6) 2023 19:43:30.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 19:53:00.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATTERY REMOVED (84) (B)(6) 2023 19:54:01.000 BATTERYINSERTED (B)(6) 2023 19:54:04.000 ALARMALERTNOTIFICATION FAULTNUMBER = POST-RESET RAM CRC ALARM (23) (B)(6) 2023 19:54:25.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT (6) (B)(6) 2023 19:54:36.000 ALARMALERTNOTIFICATION FAULTNUMBER = BATT OUT LIMIT (6) THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY 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. PUMP ERROR 23 AND BATTERY OUT LIMIT ALARM WERE DUE TO THE BATTERY REMOVED FOR MORE THAN 10 MINUTES PUMP. THE TEST BATTERY WAS REMOVED AND REINSERT IN LESS THAN 1 MINUTE INTO THE BATTERY COMPARTMENT. NO UNEXPECTED PUMP ERROR 23 OR BATTERY OUT LIMIT ALARM NOTED DURING TESTING. NO DELIVERY NOT CONFIRMED. PUMP ERROR 23 NOT CONFIRMED. BATT OUT LIMIT (6) NOT CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED DKA/HIGH BGS. BLANK DISPLAY NOT CONFIRMED. BATTERY CAP CONTACT MISSING/DAMAGED UNKNOWN. 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

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 500-600 MG/DL AT THE TIME OF THE EVENT. THE CURRENT BLOOD GLUCOSE VALUE WAS 160 MG/DL. THE CUSTOMER WAS ADMITTED TO THE HOSPITAL DUE TO DIABETIC KETOACIDOSIS AND WAS TREATED WITH INSULIN SHOTS AND INTRA VENOUS DRIP AND FLUIDS. THE CUSTOMER DISCONTINUED USING THE PUMP AND WAS CURRENTLY ON MANUAL INJECTION. THE CUSTOMER REPORTED THE PUMP WAS NOT TURNING ON AND STATED THE BATTERY CAP WAS DAMAGED. TROUBLESHOOTING WAS PERFORMED FOR THE BLANK DISPLAY AND ADVISED TO MONITOR THE PUMP FOR 2 HOURS AND FROZEN DISPLAY HAS NOT RECURRED. THE CUSTOMER REPORTED NO SYMPTOMS RELATED TO THE HIGH BLOOD GLUCOSE EVENT. TROUBLESHOOTING WAS PERFORMED. IT WAS UNKNOWN WHETHER THE CUSTOMER USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT OR NOT. IT WAS UNKNOWN WHETHER THE AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF THE EVENT OR NOT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER DISCONTINUED USING THE PUMP AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755907 630G INSULIN PUMP MMT-1715KL 630G AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG5P3PD 000000763000316655

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Hospitalization| R| O FRN-MMT-332A-RSVR, UNOMED-INF SET