BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 13115868 · Received December 30, 2021

    Report

    Report Number
    2032227-2021-236812
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    December 23, 2021
    Report Date
    June 21, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000521547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER = BLACK. THE CUSTOMER ALLEGED THE PUMP IS OVER DELIVERING CAUSING LOW BGS ON (B)(6) 2021. THE PUMP PASSED ALL FUNCTIONAL TESTING 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 TEST AT .08720 INCHES. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUMP AND CARELINK UPLOAD WAS SUCCESSFUL. NO OVER DELIVERY ANOMALY NOTED DURING TESTING. THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO DAMAGE OR MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), MOTOR, OR FORCE SENSOR. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING PHYSICAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE PUMP PASSED ALL FUNCTIONAL TESTING. OVER DELIVERY AND LOW BG ANOMALIES ARE NOT CONFIRMED. THE FORMATTED HISTORY FILE LIST THE FOLLOWING MANUAL PROGRAMMED BOLUS DELIVERIES FOR 12/23/2021: 12/23/2021 11:51 CL1GLUCOSECORRECTIONPLUSFOODBOLUS NORMALBOLUSAMOUNTPROGRAMMED: 45000 (4.5 U) BOLUSAMOUNTDELIVERED: 45000 (4.5 U). 12/23/2021 12:28 CL1GLUCOSECORRECTIONPLUSFOODBOLUS NORMALBOLUSAMOUNTPROGRAMMED: 30000 (3 U) BOLUSAMOUNTDELIVERED: 30000 (3 U). 12/23/2021 14:45 CL1GLUCOSECORRECTIONPLUSFOODBOLUS NORMALBOLUSAMOUNTPROGRAMMED: 100000 (10 U) BOLUSAMOUNTDELIVERED: 100000 (10 U). 12/23/2021 17:12 CL1GLUCOSECORRECTIONPLUSFOODBOLUS NORMALBOLUSAMOUNTPROGRAMMED: 35000 (3.5 U) BOLUSAMOUNTDELIVERED: 35000. 12/23/2021 18:03 CL1GLUCOSECORRECTIONPLUSFOODBOLUS NORMALBOLUSAMOUNTPROGRAMMED: 45000 (4.5 U) BOLUSAMOUNTDELIVERED: 45000 (4.5 U). 12/23/2021 18:28 BOLUS WIZARD NORMALBOLUSAMOUNTPROGRAMMED: 40000 (4 U) BOLUSAMOUNTDELIVERED: 40000 (4 U). 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

    (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 · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS OVER DELIVERING. THE CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 10.9 MMOL/L. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 2.8 MMOL/L. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER TREATED LOW BLOOD GLUCOSE VALUE WITH FOOD. CUSTOMER ALLEGED INSULIN PUMP WAS OVER DELIVERY BECAUSE HE WAS GETTING TOO MUCH INSULIN WHILE IN AUTO MODE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018707 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885 HG5F8HHZZ 000000763000521547

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown