BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12587302 · Received October 6, 2021

    Report

    Report Number
    2032227-2021-201881
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    September 29, 2021
    Report Date
    March 25, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK ON SEPT (B)(6), 2021, THE CUSTOMER ALLEGED WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE, DIABETIC KETOACIDOSIS AND INSULIN PUMP UNDER DELIVERY. DEVICE 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 DELIVERY ACCURACY TEST AT 0.0875 INCHES. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED. THERE WAS NO BOLUS DELIVERY ON (B)(6) 2021 (EVENT DATE).HOWEVER, THE CUSTOMER HAD BOLUS DELIVERIES ON (B)(6) 2021. (B)(6)2021 00:10:23.000 NORMAL BOLUS DELIVERED (220)NORMAL BOLUS AMOUNT PROGRAMMED: 77000 (7.7 U)BOLUS AMOUNT DELIVERED: 77000 (7.7 U)09/26/2021 00:33:55.000 NORMAL BOLUS DELIVERED (220) NORMAL BOLUS AMOUNT PROGRAMMED: 52000 (5.2 U) BOLUS AMOUNT DELIVERED: 52000 (5.2 U) (B)(6)2021 02:33:41.000 NORMAL BOLUS DELIVERED (220)NORMAL BOLUS AMOUNT PROGRAMMED: 30000 (3 U) BOLUS AMOUNT DELIVERED: 30000 (3 U) (B)(6) 2021 03:02:37.000 NORMAL BOLUS DELIVERED (220) NORMAL BOLUS AMOUNT PROGRAMMED: 26000 (2.6 U) BOLUS AMOUNT DELIVERED: 26000 (2.6 U) NO SUSPEND ANOMALY OR NO DELIVERY ALARM NOTED IN THE HISTORY FILE. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE AND A PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. IN SUMMARY, INSULIN PUMP PASSED ALL REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BLOOD GLUCOSE AND DKA. CUSTOMER ALLEGED FOR THE INSULIN PUMP UNDER DELIVERY WAS NOT CONFIRMED THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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

    DEVICE 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 DELIVERY ACCURACY TEST. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED. THERE WAS NO BOLUS DELIVERY ON (B)(6) 2021 (EVENT DATE). HOWEVER, THE CUSTOMER HAD BOLUS DELIVERIES ON (B)(6) 2021. (B)(6) 2021 00:10:23.000 NORMAL BOLUS DELIVERED (220) NORMAL BOLUS AMOUNT PROGRAMMED: 77000 (7.7 UNITS) BOLUS AMOUNT DELIVERED: 77000 (7.7 UNITS) (B)(6) 2021 00:33:55.000 NORMAL BOLUS DELIVERED (220) NORMAL BOLUS AMOUNT PROGRAMMED: 52000 (5.2 UNITS) BOLUS AMOUNT DELIVERED: 52000 (5.2 UNITS) (B)(6) 2021 02:33:41.000 NORMAL BOLUS DELIVERED (220) NORMAL BOLUS AMOUNT PROGRAMMED: 30000 (3 UNITS) BOLUS AMOUNT DELIVERED: 30000 (3 UNITS) (B)(6) 2021 03:02:37.000 NORMAL BOLUS DELIVERED (220) NORMAL BOLUS AMOUNT PROGRAMMED: 26000 (2.6 UNITS) BOLUS AMOUNT DELIVERED: 26000 (2.6 UNITS) NO SUSPEND ANOMALY OR NO DELIVERY ALARM NOTED IN THE HISTORY FILE. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, SCRATCHED CASE AND A PILLOWING KEYPAD OVERLAY. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. (B)(4). 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 WERE HOSPITALIZED ON (B)(6) 2021 DUE TO HIGH BLOOD GLUCOSE LEVEL FOR THREE DAYS AND DIABETES KETO ACIDOSIS FOR OVERNIGHT STAY. THE BLOOD GLUCOSE LEVEL OF CUSTOMER WAS 900 MG/DL. THE CURRENT BLOOD GLUCOSE LEVEL OF CUSTOMER WAS 139 MG/DL. IT WAS KNOWN THAT CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED EVENT. AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF INCIDENT. CUSTOMER ALLEGED THAT INSULIN PUMP WAS UNDER DELIVERING INSULIN. IT WAS KNOWN THAT CUSTOMER HAD EXPERIENCED SYMPTOM RELATED WITH INCIDENT INCLUDING FEELING UNWELL OR SICK, FLUE LIKE, ALTERED VISION OR VISION CHANGE, INCREASED THIRST, POLYURIA, HEADACHE. CUSTOMER WAS TREATED WITH INTRAVENOUS INSULIN DRIP AND MANUAL INSULIN INJECTION OR INSULIN PEN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484484 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 HG4V1NNZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Hospitalization FRN-UNK-RSVR , UNOMED SET, OZP-MMT-7020-SNSR| FRN-UNK-RSVR , UNOMED SET, OZP-MMT-7020-SNSR