BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13838047 · Received March 21, 2022

    Report

    Report Number
    2032227-2022-168352
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    September 28, 2021
    Report Date
    March 21, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. CUSTOMER COMPLAINED ON (B)(6) 2021 THE PUMP ALARMED PUMP ERROR 41 AND PUMP ERROR 43.UNIT PASSED DISPLACEMENT TEST, SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST AND OCCLUSION TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUMPS. NO PUMP ERROR 41 OR PUMP ERROR 43 ALARMS NOTED DURING TEST. VERIFIED PUMP ALARMED PUMP ERROR 41 ON (B)(6) 2021 13:07:00.000 AND PUMP ERROR 43 ON (B)(6) 2021 13:07:00.000 IN PUMP DOWNLOADED HISTORY DUE TO CORRODED MOTOR HOME SWITCH. NO MOISTURE DAMAGE NOTED ON ELECTRONIC ASSEMBLY PER VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED KEYPAD OVERLAY. SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO PUMP ERROR 41 OR PUMP ERROR 43 ALARMS NOTED DURING TEST AND VERIFIED PUMP ALARMED PUMP ERROR 41 ON (B)(6) 2021 13:07:00.000 AND PUMP ERROR 43 ON (B)(6) 2021 13:07:00.000 IN PUMP DOWNLOADED HISTORY DUE TO CORRODED MOTOR HOME SWITCH.

    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 ABLE TO COMPLETE REWIND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680408 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 HG51Z5AZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male