BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 18843730 · Received March 6, 2024

    Report

    Report Number
    2032227-2024-137059
    Event Type
    Death
    Date Received
    March 6, 2024
    Date of Event
    January 24, 2024
    Report Date
    March 5, 2024
    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
    OH, 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) 2024, THERE IS NO UNEXPECTED SUSPENDS AND NO BOLUS DELIVERY NOTED. HOWEVER, PUMP ERROR 53 ALARM WAS NOTED. PLEASE SEE BELOW FOR THE DAILY TOTAL OF BASAL/BOLUS AND ALL INSULIN DELIVERED ON THE EVENT DATE OF (B)(6) 2024 LISTED ON SMARTSOLVE. DAILYTOTALCOLLECTIONSTARTTIME = (B)(6) 2024 00:00:00.000. DAILYTOTALOFALLINSULINDELIVERED = 9.95. DAILYTOTALOFBASALINSULINDELIVERED = 9.95. DAILYTOTALOFBOLUSINSULINDELIVERED = 0. 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. PUMP ERROR 53 ALARM (FILE NUMBER: 2005 LINE NUMBER: 5632) WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2024 16:59:29.000. PUMP ERROR 53 ALARM (FILE NUMBER: 2005 LINE NUMBER: 5632) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO SOFTWARE ERROR. PLEASE SEE BELOW FOR PUMP ERRORS/ALARMS NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6) 2024 IN THE FORMATTED HISTORY FILE.  INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2024 16:41:09.000, (B)(6) 2024 16:48:05.000, (B)(6) 2024 16:58:00.000. FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2024 16:45:52.000. PUMP ERROR 23 ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2024 16:59:03.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2024 16:59:31.000. 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. INSERT BATTERY ALARM WAS EXPECTED SINCE THE BATTERY WAS REMOVED FROM THE PUMP. UPON CHECKING ON THE POWER DATA/DETAIL TRACE FILE, FAILED BATTERY ALERT/BATTERY FAILED ALARM WAS EXPECTED DUE TO PUMP BATTERY DOES NOT HAVE ENOUGH POWER. THE CUSTOMER MAY HAVE USED A NO POWER/DEPLETED BATTERY. PUMP ERROR 23 ALARM AND POWER LOSS ALARM WERE EXPECTED SINCE THE PUMP RESETS AFTER THE BATTERY WAS REMOVED FOR MORE THAN 10 MINUTES. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A SCRATCHED CASE. 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. PLEASE SEE BELOW FOR THE CUSTOMER'S DAILY TOTAL OF ALL INSULIN DELIVERED SURROUNDING THE EVENT DATE (B)(6) 2024 LISTED ON SMARTSOLVE AND THE DAYS PRIOR TO THE EVENT DATE. (B)(6) 2024, DAILYTOTALOFALLINSULINDELIVERED = 14.55; (B)(6) 2024, DAILYTOTALOFALLINSULINDELIVERED = 14.55; (B)(6) 2024, DAILYTOTALOFALLINSULINDELIVERED = 14.55; (B)(6) 2024, DAILYTOTALOFALLINSULINDELIVERED = 14.55; (B)(6) 2024, DAILYTOTALOFALLINSULINDELIVERED = 14.55; (B)(6) 2024, DAILYTOTALOFALLINSULINDELIVERED = 14.55; (B)(6) 2024, DAILYTOTALOFALLINSULINDELIVERED = 14.55; (B)(6) 2024, DAILYTOTALOFALLINSULINDELIVERED = 14.55; (B)(6) 2024, DAILYTOTALOFALLINSULINDELIVERED = 14.55; (B)(6) 2024, DAILYTOTALOFALLINSULINDELIVERED = 9.95. THE PUMP PASSED ALL THE REQUIRED TESTING. HOWEVER, PUMP ERROR 53 ALARM (FILE NUMBER: 2005 LINE NUMBER: 5632) WAS CONFIRMED ACCORDING IN THE FORMATTED HISTORY FILE DUE TO SOFTWARE ERROR. 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 PASSED AWAY ON (B)(6) 2024. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CAUSE OF DEATH WAS DUE TO PNEUMONIA CUSTOMER WAS HOSPITALIZED. THE BLOOD GLUCOSE LEVEL AT THE TIME OF DEATH WAS UNKNOWN. THE CUSTOMER WAS NOT WEARING THE PUMP AT THE TIME OF PASSING. IT WAS UNKNOWN WHETHER CUSTOMER USING THE PUMP WITHIN 48 HOURS OF THE REPORTED EVENT OR NOT AND ITS UNKNOWN WHETHER ITS IN AUTO MODE AT THE TIME EVENT. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565295 630G INSULIN PUMP MMT-1715KL 630G AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL NG3493354H 000000763000316655

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death