BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13727246 · Received March 10, 2022

    Report

    Report Number
    2032227-2022-126858
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    October 23, 2021
    Report Date
    May 2, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. (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.

    Additional Manufacturer Narrative · 0

    RETAINER = BLACK. CUSTOMER RETURNED THE INSULIN PUMP FOR ALLEGED PUMP ERROR 15, PUMP ERROR 4, AND PUMP ERROR 23 ALARMS FOUND ON 10/23/2021. INSULIN PUMP PASSED ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT TEST, SELF TEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. NO PUMP ERROR 15, PUMP ERROR 4 OR PUMP ERROR 23 NOTED DURING TEST. INSULIN PUMP SUCCESSFULLY DOWNLOADED TO THUMP. VERIFIED INSULIN PUMP ALARMED NORMAL PUMP ERROR 23 AFTER BATTERY INSTALLATION ON 10/23/2021 19:58:10.000. VERIFIED INSULIN PUMP ALARMED PUMP ERROR 4 ON 10/23/2021 19:58:08.000 AND PUMP ERROR 15 (LINE NUMBER 442 FILE NUMBER 38) IN THE INSULIN PUMP HISTORY DOWNLOAD ON 10/23/2021 19:58:08.000 DUE TO MOISTURE DAMAGE TO THE ELECTRICAL BOARD AS PER GLOBAL LOGIC ANALYSIS ESF3764385. NO MOISTURE DAMAGE NOTED TO THE MOTOR ASSEMBLY PER VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO PUMP ERROR 15, PUMP ERROR 4 OR PUMP ERROR 23 NOTED DURING TEST. CONFIRMED INSULIN PUMP ALARMED NORMAL PUMP ERROR 23 AFTER BATTERY INSTALLATION ON 10/23/2021 19:58:10.000. CONFIRMED INSULIN PUMP ALARMED PUMP ERROR 4 ON 10/23/2021 19:58:08.000 AND PUMP ERROR 15 (LINE NUMBER 442 FILE NUMBER 38) IN THE INSULIN PUMP HISTORY DOWNLOAD ON 10/23/2021 19:58:08.000 DUE TO MOISTURE DAMAGE TO THE ELECTRICAL BOARD AS PER GLOBAL LOGIC ANALYSIS ESF3764385. 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

    MEDTRONIC RECEIVED INFORMATION THAT PUMP ERROR 4, PUMP ERROR 23, PUMP ERROR 15 OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658605 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 HG52VRTZZ 000000763000384289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown