BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 17268850 · Received July 6, 2023

    Report

    Report Number
    2032227-2023-232422
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    June 18, 2023
    Report Date
    August 28, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 0.0869 INCHES. NO PUMP ERROR 43 NOTED DURING TESTING. HOWEVER, THERE MULTIPLE PUMP ERROR 43 WAS CONFIRMED IN THE PUMP HISTORY FILE. PLEASE SEE THE FIRST LISTED PUMP ERROR 43 BELOW. PUMP ERROR 43 WAS CONFIRMED ON 06/18/2023 09:50:00.000 IN THE PUMP HISTORY FILE. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY AND ON THE MOTOR. PUMP ERROR 43 WAS CONFIRMED ON 06/04/2023 11:42:00.000 IN THE PUMP HISTORY FILE DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY AND ON THE MOTOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE, CRACKED CASE ABOVE THE LOCK ICON AT THE BATTERY COMPARTMENT AND PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP. THE PUMP DID NOT HAVE A BATTERY INSTALLED WHEN RECEIVED. NO DAMAGE NOTED ON THE ORIGINAL BATTERY CAP. PLEASE SEE BELOW FOR THE PUMP ERROR(S)/ALARM(S) NOTED 2 DAYS PRIOR TO THE EVENT DATE 18-JUN-2023 IN THE PUMP HISTORY FILE. 06/17/2023 18:30:47.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/17/2023 18:40:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/17/2023 18:59:03.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MOTORDRIVEERROR (43). 06/17/2023 19:09:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MOTORDRIVEERROR (43). 06/17/2023 19:12:32.000 BATTERYREMOVED (55). 06/17/2023 19:12:32.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:12:32.000 BATTERYINSERTED (44). 06/17/2023 19:12:32.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:12:38.000 BATTERYREMOVED (55). 06/17/2023 19:12:38.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:12:38.000 BATTERYINSERTED (44). 06/17/2023 19:12:38.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:12:47.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:12:47.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOWBATTERYALERT (104). 06/17/2023 19:13:12.000 BATTERYREMOVED (55). 06/17/2023 19:13:12.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:13:12.000 BATTERYINSERTED (44). 06/17/2023 19:13:12.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:13:18.000 BATTERYREMOVED (55). 06/17/2023 19:13:18.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:13:18.000 BATTERYINSERTED (44). 06/17/2023 19:13:18.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:13:24.000 BATTERYREMOVED (55). 06/17/2023 19:13:24.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:13:24.000 BATTERYINSERTED (44). 06/17/2023 19:13:24.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:13:29.000 BATTERYREMOVED (55), 06/17/2023 19:13:29.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:13:29.000 BATTERYINSERTED (44). 06/17/2023 19:13:29.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:13:35.000 BATTERYREMOVED (55). 06/17/2023 19:13:35.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:16:21.000 BATTERYINSERTED (44). 06/17/2023 19:16:21.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:16:28.000 BATTERYREMOVED (55). 06/17/2023 19:16:28.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:16:28.000 BATTERYINSERTED (44). 06/17/2023 19:16:28.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:16:34.000 BATTERYREMOVED (55). 06/17/2023 19:16:34.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:16:34.000 BATTERYINSERTED (44). 06/17/2023 19:16:34.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:16:44.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:16:44.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOWBATTERYALERT (104). 06/17/2023 19:17:02.000 BATTERYREMOVED (55). 06/17/2023 19:17:02.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:17:02.000 BATTERYINSERTED (44). 06/17/2023 19:17:02.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:17:08.000 BATTERYREMOVED (55). 06/17/2023 19:17:08.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:17:08.000 BATTERYINSERTED (44). 06/17/2023 19:17:08.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:17:14.000 BATTERYREMOVED (55). 06/17/2023 19:17:14.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:17:14.000 BATTERYINSERTED (44). 06/17/2023 19:17:14.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:17:23.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:17:23.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOWBATTERYALERT (104). 06/17/2023 19:17:43.000 BATTERYREMOVED (55). 06/17/2023 19:17:43.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:17:43.000 BATTERYINSERTED (44). 06/17/2023 19:17:43.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:17:52.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:17:52.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOWBATTERYALERT (104). 06/17/2023 19:20:33.000 BATTERYREMOVED (55). 06/17/2023 19:20:33.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:21:12.000 BATTERYINSERTED (44). 06/17/2023 19:21:12.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:21:23.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:21:23.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOWBATTERYALERT (104). 06/17/2023 19:21:40.000 BATTERYREMOVED (55). 06/17/2023 19:21:40.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:21:40.000 BATTERYINSERTED (44). 06/17/2023 19:21:40.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:21:49.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: FAILEDBATTTEST (58). 06/17/2023 19:21:49.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: LOWBATTERYALERT (104). 06/17/2023 19:22:02.000 BATTERYREMOVED (55). 06/17/2023 19:22:02.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/17/2023 19:22:14.000 BATTERYINSERTED (44). 06/17/2023 21:04:10.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: NODELIVERY (7). 06/17/2023 21:04:54.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: NODELIVERY (7). 06/17/2023 21:06:01.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: NODELIVERY (7). 06/18/2023 09:43:18.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 09:50:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MOTORDRIVEERROR (43). 06/18/2023 09:50:08.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 09:50:33.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MOTORDRIVEERROR (43). 06/18/2023 09:51:03.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 09:51:11.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 10:01:09.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MOTORDRIVEERROR (43). 06/18/2023 10:11:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MOTORDRIVEERROR (43). 06/18/2023 10:29:26.000 BATTERYREMOVED (55). 06/18/2023 10:29:26.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/18/2023 10:38:24.000 BATTERYREMOVED (55). 06/18/2023 10:38:24.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/18/2023 10:38:49.000 BATTERYINSERTED (44). 06/18/2023 10:41:55.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 10:42:03.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 10:51:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 15:30:25.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MOTORPOWERREQUESTTIMEOUTALARM (82). 06/18/2023 15:30:39.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MOTORPOWERREQUESTTIMEOUTALARM (82). 06/18/2023 15:54:08.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MOTORDRIVEERROR (43). 06/18/2023 15:55:24.000 BATTERYREMOVED (55). 06/18/2023 15:55:24.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/18/2023 15:55:34.000 BATTERYREMOVED (55). 06/18/2023 15:55:34.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/18/2023 16:05:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). 06/18/2023 17:11:37.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTOUTLIMIT (6). 06/18/2023 17:12:03.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 17:12:16.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: STUCKMOTORALARM (38). 06/18/2023 17:15:05.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MOTORDRIVEERROR (43). 06/18/2023 17:17:35.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 17:17:45.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 17:23:24.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MOTORPOWERREQUESTTIMEOUTALARM (82). 06/18/2023 17:25:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MOTORDRIVEERROR (43). 06/18/2023 17:27:03.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 17:27:08.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 17:27:23.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 17:37:00.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 17:39:03.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 17:39:18.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MOTORDRIVEERROR (43). 06/18/2023 17:39:22.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: MFDAALARM (130). 06/18/2023 17:45:06.000 BATTERYREMOVED (55). 06/18/2023 17:45:06.000 ALARMALERTNOTIFICATION (40), FAULTNUMBER: BATTERYREMOVED (84). LOW BATTERY ALERT WAS DUE TO THE CUSTOMER'S BATTERY IN THE PUMP IS LOW ON POWER. 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 TEST BATTERY WAS REMOVED AND REINSERTED WITH NO FAILED BATTERY TEST ALARM OR BATTERY OUT LIMIT ALARM NOTED. PUMP ERROR 43, PUMP ERROR 130 AND PUMP ERROR 82 WERE CONFIRMED IN THE PUMP HISTORY FILE (SEE ABOVE FOR THE DATES AND TIMES) DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY AND ON THE MOTOR. PUMP ERROR 130 CONFIRMED IN THE PUMP HISTORY FILE. PUMP ERROR 43 CONFIRMED IN THE PUMP HISTORY FILE. FAILEDBATTTEST (58) NOT CONFIRMED. LOWBATTERYALERT (104) NOT CONFIRMED. PUMP ERROR 82 CONFIRMED IN THE PUMP HISTORY FILE. BATTOUTLIMIT (6) NOT CONFIRMED. PUMP ERROR 43 CONFIRMED IN THE PUMP HISTORY FILE. PUMP ERROR 130 CONFIRMED IN THE PUMP HISTORY FILE. PUMP ERROR 82 CONFIRMED IN THE PUMP HISTORY FILE. 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 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 EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 400 MG/DL. THE CUSTOMER ALSO REPORTED PUMP ERROR 43-¿¿ AN ERROR IN THE MOTOR WAS DETECTED BY READING UNEXPECTED VALUE FROM HALL SENSOR.¿¿ TROUBLESHOOTING WAS PERFORMED AND WAS ABLE TO CLEAR THE ALARM SUCCESSFULLY. THE CUSTOMER STATES THAT THE NOT ABLE TO REWIND THE PUMP. IT WAS FOUND THAT THE CUSTOMER WAS USING THE 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 DISCONTINUE THE USE OF THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN AS PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991287 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 HG6AAZNZZ

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other FRN-MMT-332-RSVR, UNOMED, OZP-MMT-7020-SNSR