BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12237009 · Received July 28, 2021

    Report

    Report Number
    2032227-2021-173229
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    July 18, 2021
    Report Date
    November 11, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER COMPLAINED ON (B)(6) 2021 INSULIN PUMP WENT BLANK WHILE SWIMMING FROM FLUID INSIDE INSULIN PUMP. COMPLAINED THERE IS CRACK ON THE INSULIN PUMP. DEVICE ALARMED CRITICAL PUMP ERROR AFTER BATTERY INSTALLATION. NO BLANK DISPLAY NOTED. DEVICE ALARMED CRITICAL PUMP ERROR DUE TO MOISTURE DAMAGE TO THE RF CHIP (U2) ON THE ELECTRICAL BOARD 1 AS PER GLOBAL LOGIC ANALYSIS (ESF#: (B)(4)). DEVICE SUCCESSFULLY DOWNLOADED TO THUMPS. UNABLE TO PERFORM SELFTEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, ACTIVE CURRENT MEASUREMENT AND SLEEP CURRENT MEASUREMENT TEST DUE TO CRITICAL PUMP ERROR. FOUND MOISTURE DAMAGE TO MOTOR ASSEMBLY, ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2 DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, CORRODED MOTOR HOME SWITCH, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED BATTERY TUBE THREADS AND CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO BLANK DISPLAY NOTED DURING TEST. DEVICE ALARMED CRITICAL PUMP ERROR DUE TO MOISTURE DAMAGE TO THE RF CHIP (U2) ON THE ELECTRICAL BOARD 1 AS PER GLOBAL LOGIC ANALYSIS (ESF#: (B)(4)). FOUND MOISTURE DAMAGE TO MOTOR ASSEMBLY, ELECTRICAL BOARD 1 AND ELECTRICAL BOARD 2 DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, CORRODED MOTOR HOME SWITCH, CRACKED BATTERY TUBE THREADS AND CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. 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. 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 · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S HOME SCREEN DID NOT APPEAR ON THE DISPLAY. THE INSULIN PUMP WAS EXPOSED TO MOISTURE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140610 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 HG50S1ZZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female