BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12793274 · Received November 11, 2021

    Report

    Report Number
    2032227-2021-216865
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    July 11, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING=(B)(6). CUSTOMER COMPLAINED ON (B)(6) 2021 PUMP ALARMED STUCK BUTTON, PUMP ERROR 43, PUMP ERROR 19, PUMP ERROR 37 AND PUMP ERROR 3. UNIT PASSED ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT TEST, SELFTEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. UNIT SUCCESSFULLY DOWNLOADED TO THUS. NO PUMP ERROR 37, PUMP ERROR 43, PUMP ERROR 3 OR PUMP ERROR 19 ALARMS NOTED DURING TEST. VERIFIED PUMP ALARMED PUMP ERROR 37 AT (B)(6) 2021 11:25:00.000, PUMP ERROR 43 AT (B)(6) 2021 14:38:21.000, PUMP ERROR 42 AT (B)(6) 2021 11:07:00.000 AND PUMP ERROR 19 AT (B)(6) 2021 11:09:37.000. THE MOTOR HAD A INTERMITTENT FAILURE NOT CONFIRMED DURING TEST. THE FORMATTED HISTORY FILE CONFIRMED PUMP ERROR 3 ON (B)(6) 2021 16:36:45.000 AND PUMP ERROR 53 ALARM (LINE NUMBER 458 FILE NUMBER (B)(4)) ON (B)(6) 2021 11:13:09.000 DUE TO FAULTY VOLTAGE REGULATOR ON THE PCB2 BOARD. NO STUCK BUTTON ERROR ALARMS NOTED DURING TESTING. VERIFIED PUMP ALARMED STUCK BUTTON ON (B)(6) 2021 13:47:36.000 IN PUMP DOWNLOADED HISTORY. UNIT PASSED THE KEYPAD VOLTAGE TEST. NO DAMAGE WAS NOTED TO KEYPAD ASSEMBLY AND J1 CONNECTOR ON PCB1 WAS LOCKED PROPERLY DURING VISUAL INSPECTION. THE ELECTRONIC ASSEMBLIES AND MOTOR ASSEMBLIES WERE INSPECTED AND NO ANOMALIES NOTED. MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED KEYPAD OVERLAY. THE P-CAP/ RESERVOIR DOES LOCK PROPERLY. NO PUMP ERROR 37, PUMP ERROR 43, PUMP ERROR 3 OR PUMP ERROR 19 ALARMS NOTED DURING TEST. VERIFIED PUMP ALARMED PUMP ERROR 37 AT (B)(6) 2021 11:25:00.000, PUMP ERROR 43 AT (B)(6) 2021 14:38:21.000, PUMP ERROR 42 AT (B)(6) 2021 11:07:00.000 AND PUMP ERROR 19 AT (B)(6) 2021 11:09:37.000. THE MOTOR HAD A INTERMITTENT FAILURE NOT CONFIRMED DURING TEST. THE FORMATTED HISTORY FILE CONFIRMED PUMP ERROR 3 ON (B)(6) 2021 16:36:45.000 AND PUMP ERROR 53 ALARM (LINE NUMBER 458 FILE NUMBER 32107) ON (B)(6) 2021 11:13:09.000 DUE TO FAULTY VOLTAGE REGULATOR ON THE PCB2 BOARD. NO STUCK BUTTON ERROR ALARMS NOTED DURING TESTING. VERIFIED PUMP ALARMED STUCK BUTTON ON (B)(6) 2021 13:47:36.000 IN PUMP DOWNLOADED HISTORY. (B)(4).

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A PUMP ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND WERE ABLE TO COMPLETE THE REWIND PROCESS. 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
    1690398 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 HG559D4ZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male