BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12224138 · Received July 26, 2021

    Report

    Report Number
    2032227-2021-172094
    Event Type
    Injury
    Date Received
    July 26, 2021
    Date of Event
    July 15, 2021
    Report Date
    January 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK DEVICE PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DELIVERY ACCURACY TEST AT 0.08710 INCHES. NO BLANK DISPLAY DURING TESTING. THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. NO DAMAGE ON THE RETAINER DURING VISUAL INSPECTION. HOWEVER, INSULIN PUMP RECEIVED WITH A HIGH SLEEP CURRENT MEASUREMENT AND UNABLE TO DOWNLOAD TO THUMP SOFTWARE. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION, THE BATTERY TUBE CONNECTOR PLUGGED IN PROPERLY TO ELECTRICAL BOARD 1 AND FOUND MOISTURE DAMAGE ON THE J6, J7, DA1, U28 AND Q3/PCB 1. ALSO FOUND MOISTURE DAMAGE ON THE MOTOR ASSEMBLY, FORCE SENSOR, INTERNAL BATTERY TUBE CONNECTOR, KEYPAD FLEX TAIL AND BATTERY TUBE CONNECTOR. NO MOISTURE DAMAGE ON THE ELECTRICAL BOARD 2, BATTERY TUBE, KEYPAD DOME SWITCHES, KEYPAD TRACES AND VIBRATOR DURING VISUAL INSPECTION. PERFORM BRUSH CLEANING WITH THE ISOPROPYL ALCOHOL THE MOISTURE DAMAGE AREAS AND POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND THE SLEEP CURRENT IS WITHIN SPECIFICATION. HOWEVER, THE INSULIN PUMP DOWNLOADED TO THUMP AND CARE LINK SOFTWARE WAS UTILIZED AND SUCCESSFUL. IN CONCLUSION, THE HIGH SLEEP CURRENT MEASUREMENT AND UNABLE TO DOWNLOAD TO THUMP SOFTWARE DUE TO MOISTURE DAMAGE ON THE J6, J7, DA1, U28 AND Q3/PCB 1. DEVICE RECEIVED WITH PILLOWING KEYPAD OVERLAY. 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

    RETAINER RING = BLACK ON (B)(6)2021 THE CUSTOMER ALLEGED PUMP WENT BLANK AFTER LOW BATTERY ALERT AND WAS THEN HOSPITALIZED FOR LOW BLOOD GLUCOSES. DEVICE PASSED THE SELF TEST, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DELIVERY ACCURACY TEST AT 0.08710 INCHES. NO BLANK DISPLAY DURING TESTING. THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. NO DAMAGE ON THE RETAINER DURING VISUAL INSPECTION. HOWEVER, INSULIN PUMP RECEIVED WITH A HIGH SLEEP CURRENT MEASUREMENT AND UNABLE TO DOWNLOAD TO THUMP SOFTWARE. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION, THE BATTERY TUBE CONNECTOR PLUGGED IN PROPERLY TO J7/PCBA 1 AND FOUND MOISTURE DAMAGE ON THE J6, J7, DA1, U28 AND Q3/PCBA 1. ALSO FOUND MOISTURE DAMAGE ON THE MOTOR ASSEMBLY, FORCE SENSOR, INTERNAL BATTERY TUBE CONNECTOR, KEYPAD FLEX TAIL AND BATTERY TUBE CONNECTOR. NO MOISTURE DAMAGE ON THE PCBA 2, BATTERY TUBE, KEYPAD DOME SWITCHES, KEYPAD TRACES AND VIBRATOR DURING VISUAL INSPECTION. PERFORM BRUSH CLEANING WITH THE ISOPROPYL ALCOHOL THE MOISTURE DAMAGE AREAS AND POWERED THE INSULIN PUMP ON USING THE BATTERY SIMULATOR AND THE SLEEP CURRENT IS WITHIN SPECIFICATION. HOWEVER, THE INSULIN PUMP DOWNLOADED HISTORY FILES AND TRACES USING THUMP AND CARELINK SOFTWARE WAS UTILIZED AND SUCCESSFUL. DEVICE THE POWER MANAGEMENT GRAPH DOES INDICATE SHORT BATTERY LIFETIME. NO ALARMS OR ALERTS NOTED DURING TESTING, HOWEVER, A BATTERY REMOVED ALERT [(B)(6) 2021 7:57, 07:58, 07:59, 08:09, 08:13, 09:23, (B)(6) 2021 00:59, 01:09], LOW BATTERY ALERT [(B)(6) 2021 06:26 AND (B)(6) 2021 01:11], CHANGE BATTERY FAULT ALERT [(B)(6) 2021 19:21, 19:31], OFF NO POWER ALERTS [(B)(6) 2021 19:52], BATTERY OUT LIMIT ALERT [(B)(6) 2021 00:51, 01:10], AND TWELVE FAILED BATTERY TEST ALERTS [(B)(6) 2021 07:53] WERE FOUND IN THE HISTORY FILE DUE TO MOISTURE DAMAGE ON PCBA 1. DEVICE RECEIVED WITH PILLOWING KEYPAD OVERLAY. UNABLE TO VERIFY CUSTOMER ALLEGED FOR LOW BLOOD GLUCOSES. THE HIGH SLEEP CURRENT MEASUREMENT AND UNABLE TO DOWNLOAD TO THUMP SOFTWARE DUE TO MOISTURE DAMAGE ON THE J6, J7, DA1, U28 AND Q3/PCBA 1. BLANK DISPLAY IS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD DIABETIC KETO ACIDOSIS. CUSTOMER STATED RESERVOIR MUST HAD LEAKED IN INSULIN PUMP. CUSTOMER REPORTED THAT THEY GOT A LOW BATTERY WARNING AND THEN THE INSULIN PUMP BATTERY DIED AND HAD BLANK DISPLAY. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS CURRENT OF REPORTED HIGH BLOOD GLUCOSE EVENT. IT WAS UNKNOWN THAT AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF HIGH BLOOD GLUCOSE EVENT. CUSTOMER DECLINED FOR TROUBLESHOOT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121776 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 HG4YACBZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Other FRN-MMT-332A, UNOMED SET, OZO-MMT-7020A| FRN-MMT-332A, UNOMED SET, OZO-MMT-7020A