BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13824662 · Received March 19, 2022

    Report

    Report Number
    2032227-2022-154881
    Event Type
    Malfunction
    Date Received
    March 19, 2022
    Date of Event
    September 12, 2021
    Report Date
    March 17, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORTS IN RESPONSE TO A WARNING LETTER. (B)(4). S/W VERSION 5.2A. RETAINER RING=BLACK. CUSTOMER COMPLAINED ON 09/12/2021 THE PUMP ALARMED INSULIN FLOW BLOCKED AND PUMP ERROR 82. UNIT PASSED THE SELF TEST, DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. NO PUMP ERROR 82 ALARMS OR UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. UNIT SUCCESSFULLY DOWNLOADED TO THUMPS. CONFIRMED IN THE PUMP HISTORY DOWNLOAD THE PUMP ALARMED INSULIN FLOW BLOCKED ALARM ON 09/12/2021 08:00:00.000 AND PUMP ERROR 82 ON 09/12/2021 08:01:00.000 DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD. FOUND MOISTURE DAMAGE TO MOTOR ASSEMBLY, PCB1 BOARD AND PCB2 BOARD DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, CORRODED MOTOR HOME SWITCH, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED CASE ABOVE THE ARROW AND BATTERY CAP ICON. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO PUMP ERROR 82 ALARMS OR UNEXPECTED INSULIN FLOW BLOCKED ALARMS NOTED DURING TESTING. HOWEVER, CONFIRMED IN THE PUMP HISTORY DOWNLOAD THE PUMP ALARMED INSULIN FLOW BLOCKED ALARM ON 09/12/2021 08:00:00.000 AND PUMP ERROR 82 ON 09/12/2021 08:01:00.000 DUE TO MOISTURE DAMAGE TO THE PCB1 BOARD.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PUMP ERROR 82, NO DELIVERY/OCCLUSION ALARM - UNKNOWN TIMING 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
    631805 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 HG599U0ZZ 000000763000439859

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown