BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 18593987 · Received January 29, 2024

    Report

    Report Number
    2032227-2024-116431
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    January 7, 2024
    Report Date
    March 1, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    PMA / PMN Number
    P150001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS HOSPITALIZED FOR ALLEGED HIGH BGS AND THE CUSTOMER REPORTED THAT THE PUMP HAS BEEN DROPPED (COSMETIC DAMAGE, HOWEVER NO SIGNS OF PHYSICAL DAMAGE WAS NOTED) ON EVENT (B)(6) 2024. 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 0.0871 INCHES. DURING VISUAL INSPECTION, THE PUMP WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS, CRACKED CASE AT THE BATTERY TUBE SIDE, MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED DISPLAY WINDOW COVER, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. THE PUMP WAS RECEIVED WITHOUT THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW FOR THE BOLUSES LISTED ON THE EVENT DATE (B)(6) 2024 IN THE PUMP HISTORY FILE. (B)(6) 2024 07:34:41.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 55000 (5.5 U) BOLUSAMOUNTDELIVERED: 55000 (5.5 U) (B)(6) 2024 14:24:55.000 NORMALBOLUSDELIVERED (220) SYSTEMTIME = (B)(6) 2024 14:24:55.000 NORMALBOLUSAMOUNTPROGRAMMED: 61000 (6.1 U) BOLUSAMOUNTDELIVERED: 61000 (6.1 U) (B)(6) 2024 17:06:53.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 23000 (2.3 U) BOLUSAMOUNTDELIVERED: 23000 (2.3 U) (B)(6) 2024 20:20:25.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: BOLUSWIZARD (1) NORMALBOLUSAMOUNTPROGRAMMED: 34000 (3.4 U) BOLUSAMOUNTDELIVERED: 34000 (3.4 U) PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE (B)(6) 2024 IN THE PUMP HISTORY FILE. (B)(6) 2024 00:00:00.000 DAILYTOTALSG670 (63) DAILYTOTALCOLLECTIONSTARTTIME: (B)(6) 2024 00:00:00.000 DAILYTOTALOFALLINSULINDELIVERED: 258000 (25.8 U) DAILYTOTALOFBASALINSULINDELIVERED: 85000 (8.5 U) DAILYTOTALOFBOLUSINSULINDELIVERED: 173000 (17.3 U) THERE WERE NO AUTOSUSPEND (12) ALARM NOTED IN THE PUMP HISTORY FILE. THERE WERE NO USERSUSPENDED (2) ALARM NOTED ON THE EVENT DATE (B)(6) 2024 IN THE PUMP HISTORY FILE. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 1 WEEK PRIOR TO THE EVENT DATE (B)(6) 2024 IN THE PUMP HISTORY FILE. (B)(6) 2024 15:46:45.000 BATTERYREMOVED (55) (B)(6) 2024 15:46:45.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2024 15:48:38.000 BATTERYINSERTED (44) (B)(6) 2024 15:48:38.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2024 15:48:47.000 BATTERYREMOVED (55) (B)(6) 2024 15:48:47.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2024 15:48:58.000 BATTERYINSERTED (44) (B)(6) 2024 15:48:58.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2024 15:48:59.000 BATTERYREMOVED (55) (B)(6) 2024 15:48:59.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2024 15:49:03.000 BATTERYINSERTED (44) (B)(6) 2024 15:49:03.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2024 15:49:04.000 BATTERYREMOVED (55) (B)(6) 2024 15:49:04.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2024 15:49:07.000 BATTERYINSERTED (44) (B)(6) 2024 15:49:07.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: FAILEDBATTTEST (58) (B)(6) 2024 15:49:16.000 BATTERYREMOVED (55) (B)(6) 2024 15:49:16.000 ALARMALERTNOTIFICATION (40) FAULTNUMBER: BATTERYREMOVED (84) (B)(6) 2024 15:50:49.000 BATTERYINSERTED (44) FAILED BATTERY TEST ALARM WAS EXPECTED DUE TO THE CUSTOMER'S BATTERY INSERTED ON A BATTERY CHANGE DOES NOT HAVE SUFFICIENT VOLTAGE. THE POWER MANAGEMENT TOOL CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPEC RANGE. FAILEDBATTTEST (58) NOT CONFIRMED. THE PUMP PASSED THE FUNCTIONAL TESTING. UNABLE TO CONFIRM ALLEGED HIGH BGS. COSMETIC DAMAGE WAS CONFIRMED AT THE BACK OF THE PUMP AND AT THE FRONT OF THE PUMP. 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 631 MG/DL. THE CUSTOMER REPORTED THIRST AS SYMPTOMS. TROUBLESHOOTING WAS PERFORMED. IT WAS FOUND THAT THE CUSTOMER HAS TREATED THE HIGH BLOOD GLUCOSE EVENT WITH THE EMERGENCY MEDICAL SERVICES. IT WAS UNKNOWN IF THE CUSTOMER WAS USING THE PUMP WITHIN 48 HOURS OF THE REPORTED EVENT. THE AUTO-MODE FEATURE WAS NOT ACTIVE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE CUSTOMER WILL DISCONTINUE THE USE OF THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825558 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 HG69UEWZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other| R FRN-MMT-332-RSVR, UNOMED INF SET