BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 11647301 · Received April 12, 2021

    Report

    Report Number
    2032227-2021-134036
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    April 6, 2021
    Report Date
    August 17, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PASSED ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT TEST, SELFTEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. DEVICE SUCCESSFULLY DOWNLOADED TRACES AND HISTORY FILE USING THUMP. DEVICE WAS CONNECTED TO A TEST METER, ACCU-CHECK GUIDE LINK, AND WAS ABLE TO CONNECT. DEVICE CONNECTED TO THE MINIMED MOBILE APP SUCCESSFULLY ON BOTH ANDROID AND IOS. THE FORMATTED HISTORY FILE CONFIRMED PUMP ERROR 53 ALARM (LINE NUMBER (B)(4) FILE NUMBER (B)(4)). PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY AS PER GLOBAL LOGIC ANALYSIS (ESF# (B)(4)). PUMP ERROR 15 ALARM (LINE NUMBER (B)(4), FILE NUMBER (B)(4)) IS FOUND IN THE FORMATTED HISTORY FILE. PROBLEM ISOLATED TO THE ELECTRONIC ASSEMBLY AS PER GLOBAL LOGIC ANALYSIS. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. DEVICE TRANSFERRED TO RESEARCH AND DEVELOPMENT FOR FURTHER TESTING. 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD THE CRITICAL BLOCK AND INVERSE CRITICAL BLOCK DID NOT ADD TO ZERO PUMP ERROR ALARM OCCURRED LAST NIGHT. CUSTOMER STATED CANNULA FILL AND AUTO TEST. THE INSULIN PUMP WAS OK. MOBILE AND METER RECONNECTED SUCCESSFULLY BUT DURING TRANSMITTER PAIRING SOFTWARE ERROR DETECTED ALARM OCCURRED AND PUMP REBOOTED. TRIED AGAIN TRANSMITTER PAIRING BUT STILL INSULIN PUMP ERROR REBOOT OCCURRED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550040 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 HG4R1JZZZ 000000763000384289

    Patients

    Seq Age Sex Outcome Treatment
    1