BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 15091658 · Received July 25, 2022

    Report

    Report Number
    2032227-2022-299657
    Event Type
    Injury
    Date Received
    July 25, 2022
    Date of Event
    July 1, 2022
    Report Date
    November 19, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). S.W VERSION 5.2A. RETAINER RING = BLACK. CUSTOMER RETURNED PUMP FOR AN ALLEGED POSSIBLE UNDER DELIVERY AND WAS HOSPITALIZED FOR HIGH BGS AND DKA FOUND ON (B)(6) 2022. 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 0.08660 INCHES. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. SUCCESSFULLY UPLOADED PUMP TO CARELINK. IN FURTHER FULL REVIEW OF THE PUMP HISTORY/TRACES ON THE EVENT DATE OF (B)(6) 2022, THERE WAS NO UNEXPECTED ALARMS/SUSPENDS AND FOUND BOLUS WIZARD DELIVERY OF DAILYTOTALOFBOLUSINSULINDELIVERED: 553000 (55.3 U). (B)(6) 2022 04:07:49.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 70000 (7 U) BOLUSAMOUNTDELIVERED: 70000 (7 U) (B)(6) 2022 07:57:39.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 41000 (4.1 U) BOLUSAMOUNTDELIVERED: 41000 (4.1 U) (B)(6) 2022 11:01:25.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 90000 (9 U) BOLUSAMOUNTDELIVERED: 90000 (9 U) (B)(6) 2022 15:03:55.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 120000 (12 U) BOLUSAMOUNTDELIVERED: 120000 (12 U) (B)(6) 2022 17:01:45.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 80000 (8 U) BOLUSAMOUNTDELIVERED: 80000 (8 U) (B)(6) 2022 18:49:41.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 71000 (7.1 U) BOLUSAMOUNTDELIVERED: 71000 (7.1 U) (B)(6) 2022 21:03:21.000 NORMALBOLUSDELIVERED (220) NORMALBOLUSAMOUNTPROGRAMMED: 81000 (8.1 U) BOLUSAMOUNTDELIVERED: 81000 (8.1 U) 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. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED DURING TESTING. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. THE PUMP PASSED ALL THE REQUIRED TESTING. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS AND DKA. CUSTOMER ALLEGED FOR POSSIBLE UNDER DELIVERY WAS 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 · 0

    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. INFORMATION HAVE BEEN CORRECTED WHICH WERE NOT CORRECT IN THE INITIAL REPORT. THE INFORMATION HAS BEEN PROVIDED IN SECTIONS B5, H6 AND H10 WITH THIS REPORT. THE INITIAL REPORT HAD INCORRECT AWARE DATE. THE CORRECT AWARE DATE IS 06-JUL-2022.

    Description of Event or Problem · 0

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS ON (B)(6) 2022 WITH A BLOOD GLUCOSE VALUE OF 778 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE VALUE WAS 224 MG/DL AND 568 MG/DL AT THE TIME OF CALL. THE CUSTOMER ALSO STATED THAT THEY INJECTED INTRAVENOUS INSULIN DRIP AT THE HOSPITAL TO TREAT HYPERGLYCEMIA. THE PATIENT ALSO EXPERIENCED PAIN, IRRITATION AND DIABETIC KETOACIDOSIS. CUSTOMER WAS NOT USING AUTO MODE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    ON (B)(6) 2022, CUSTOMER REPORTED TO MEDTRONIC THAT HE WAS HOSPITALIZED FOR TWO NIGHTS ON (B)(6) 2022, AT AN UNKNOWN TIME, FOR HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS WITH A BLOOD GLUCOSE OF 778 MG/DL AT THE TIME OF ADMISSION AND THE FOLLOWING SYMPTOMS: CONFUSION, FEELING SICK/UNWELL, TIRED/WEAK, INCREASED THIRST AND VOMITING THAT WERE TREATED WITH INTRAVENOUS INSULIN INFUSION. CUSTOMER STATES HE TESTED FOR KETONES, BUT DOES NOT RECALL THE RESULTS. SENSOR WAS NOT USED AND AUTOMODE WAS NOT ACTIVE AT THE TIME OF THE HOSPITALIZATION, BUT HE IS ALLEGING THAT HIS PUMP WAS UNDERDELIVERING BECAUSE THE PUMP WAS NOT DELIVERING INSULIN AND THERE WERE NO ERROR MESSAGES. CUSTOMER ALSO REPORTED A SKIN ISSUE ASSOCIATED WITH PRODUCT INSERTION CAUSING PAIN, IRRITATION AND BLOOD AT ABDOMINAL INSERTION SITE WITH THE REGULAR MIO INFUSION SET, WHICH HE STATES WAS NOT AN ISSUE WITH THE ADVANCED MIO INFUSION SET. HE REPORTS CURRENT BLOOD GLUCOSES ARE 224 MG/DL AND 568 MG/DL WITH NO SYMPTOMS OR BLEEDING AT TIME OF CALL, BUT HE ALSO REPORTS THAT HE DOES TAKE BABY ASPIRIN AND THE BLEEDING DOES NOT STAY STOPPED. PUMP RETURNED FOR ANALYSIS AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73336 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 HG4XJY8ZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other| H FRN-MMT-332-RSVR,UNOMED-INF SET