BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 17632900 · Received August 28, 2023

    Report

    Report Number
    2032227-2023-262823
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    August 10, 2023
    Report Date
    October 30, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 .08730 INCHES. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUMP. THE BOLUS WIZARD IS FUNCTIONING PROPERLY PER THE BOLUS WIZARD STANDARD TEST SAMPLE. THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO EVIDENCE OF PHYSICAL 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 THE PHYSICAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE PUMP PASSED ALL FUNCTIONAL TESTING. BOLUS WIZARD ANOMALY IS NOT CONFIRMED. UNDER-DELIVERY AND OVER-DELIVERY ANOMALIES ARE NOT CONFIRMED. THE PUMP HISTORY FILE LISTS 103 BOLUSES ON THE EVENT DATE, 8/10/2023. PLEASE SEE BELOW FOR THE FIRST 10 BOLUSES LISTED ON THE EVENT DATE 8/10/2023: 08/10/2023 00:01:33.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5). NORMALBOLUSAMOUNTPROGRAMMED: 500 (0.05 U) BOLUSAMOUNTDELIVERED: 500 (0.05 U). 08/10/2023 00:06:33.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5). NORMALBOLUSAMOUNTPROGRAMMED: 500 (0.05 U) BOLUSAMOUNTDELIVERED: 500 (0.05 U). 08/10/2023 00:11:33.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5). NORMALBOLUSAMOUNTPROGRAMMED: 750 (0.075 U) BOLUSAMOUNTDELIVERED: 750 (0.075 U). 08/10/2023 00:16:33.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5). NORMALBOLUSAMOUNTPROGRAMMED: 500 (0.05 U) BOLUSAMOUNTDELIVERED: 500 (0.05 U). 08/10/2023 00:21:31.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5). NORMALBOLUSAMOUNTPROGRAMMED: 500 (0.05 U) BOLUSAMOUNTDELIVERED: 500 (0.05 U). 08/10/2023 00:26:33.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5). NORMALBOLUSAMOUNTPROGRAMMED: 500 (0.05 U) BOLUSAMOUNTDELIVERED: 500 (0.05 U). 08/10/2023 00:31:31.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5). NORMALBOLUSAMOUNTPROGRAMMED: 250 (0.025 U) BOLUSAMOUNTDELIVERED: 250 (0.025 U). 08/10/2023 00:56:31.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5). NORMALBOLUSAMOUNTPROGRAMMED: 250 (0.025 U) BOLUSAMOUNTDELIVERED: 250 (0.025 U) 08/10/2023 01:06:31.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: . CL1MICROBOLUS (5). NORMALBOLUSAMOUNTPROGRAMMED: 250 (0.025 U) BOLUSAMOUNTDELIVERED: 250 (0.025 U). 08/10/2023 01:11:31.000 NORMALBOLUSDELIVERED (220) BOLUSPROGRAMMINGMETHOD: CL1MICROBOLUS (5). NORMALBOLUSAMOUNTPROGRAMMED: 250 (0.025 U) BOLUSAMOUNTDELIVERED: 250 (0.025 U). THERE WERE NO AUTO SUSPEND EVENTS ON THE EVENT DATE, 8/10/2023. THERE WERE NO USER SUSPEND EVENTS ON THE EVENT DATE, 8/10/2023. 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 REPORTED ISSUES WITH THE INSULIN PUMP AND INCORRECT BOLUS CALCULATION. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE BOLUS WIZARD PARAMETERS WERE ENTERED CORRECTLY AND THE BLOOD GLUCOSE AND CARBS WERE ENTERED CORRECTLY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317463 MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1884 NG3362287H

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male