BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13630062 · Received March 1, 2022

    Report

    Report Number
    2032227-2022-119243
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    September 9, 2021
    Report Date
    March 1, 2022
    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

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). S/W VERSION 5.2A. RETAINER RING=BLACK. CUSTOMER COMPLAINED ON (B)(6) 2021 THE PUMP ALARMED PUMP ERROR 15 AND PUMP ERROR 23. UNIT PASSED ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT TEST, SELFTEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. NO PUMP ERROR 15 OR PUMP ERROR 23 NOTED. UNIT SUCCESSFULLY DOWNLOADED TO THUMPS. VERIFIED PUMP ALARMED PUMP ERROR 23 ON 09/09/2021 12:11:10.000 IN PUMP DOWNLOADED HISTORY. THE FORMATTED HISTORY FILE CONFIRMED THE PUMP ALARMED PUMP ERROR 15 ALARM (LINE NUMBER 442 FILE NUMBER 38) ON 09/09/2021 12:11:08.000 DUE TO CORRUPTED HISTORY AS PER GLOBAL LOGIC ANALYSIS ESF3764385. THE ELECTRONIC ASSEMBLIES AND MOTOR ASSEMBLIES WERE INSPECTED AND NO ANOMALIES NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. PUMP PASSED FUNCTIONAL TESTING. NO PUMP ERROR 15 OR PUMP ERROR 23 NOTED DURING TEST. VERIFIED PUMP ALARMED PUMP ERROR 23 ON (B)(6) 2021 12:11:10.000 IN PUMP DOWNLOADED HISTORY. THE FORMATTED HISTORY FILE CONFIRMED THE PUMP ALARMED PUMP ERROR 15 ALARM (LINE NUMBER 442 FILE NUMBER 38) ON (B)(6) 2021 12:11:08.000 DUE TO CORRUPTED HISTORY AS PER GLOBAL LOGIC ANALYSIS ESF3764385.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND RECEIVE REQUEST TO REWIND THE INSULIN PUMP AND COMPLETE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS DISCONTINUE THE USE OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524992 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 HG4Y1MMZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female