BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13341330 · Received January 25, 2022

    Report

    Report Number
    2032227-2022-105932
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Date of Event
    August 17, 2021
    Report Date
    January 25, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). S.W VERSION 5.2A. RETAINER RING = BLACK. CUSTOMER RETURNED PUMP FOR AN ALLEGED LOW BATTERY LIFE OR LOW BATTERY ALERT AND LOW BATTERY ALERT LESS THAN 1 WEEK FOUND ON (B)(6) 2021. THE PUMP PASSED THE SELF TEST, DISPLACEMENT TEST AND ACTIVE CURRENT MEASUREMENT. HOWEVER, THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUMP. POWER MANAGEMENT GRAPH WAS SUCCESSFULLY GENERATED. THE LOADED VOLTAGE (LOADED VLITH) AND THE UNLOADED VOLTAGE (UNLOADED VLITH) DISPLAY AT THE POWER GRAPH MANAGEMENT TOOL SHOWS ABNORMAL BEHAVIOR. NO ALARMS OR ALERTS NOTED DURING THE TESTING. HOWEVER, INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 05:33:21.000 AND (B)(6) 2021 05:33:40.000, (B)(6) 2021 19:05:55.000, (B)(6) 2021 19:01:27.000 TO (B)(6) 2021 19:19:24.000 ,(B)(6) 2021 12:15:31.000. LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 04:46:00.000 ,(B)(6) 2021 18:30:00.000 ,(B)(6) 2021 18:29:00.000, (B)(6) 2021 06:32:00.000. FAILED BATT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 19:02:05.000 POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 19:19:57.000 AND (B)(6) 2021 19:20:05.000 AND REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 12:15:00.000 PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE PCBA1, PCBA2, FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. THE ORIGINAL PCBA2 WAS INSTALLED IN A TEST PCBA1, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP FAILED THE SLEEP CURRENT MEASUREMENT. THE ORIGINAL PCBA1 WAS INSTALLED IN A TEST PCBA2, CASE, INTERNAL BATTERY AND MOTOR. POWERED THE PUMP ON USING THE BATTERY SIMULATOR AND CONTINUED TESTING. THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT. THE PUMP HAD A HIGH SLEEP CURRENT MEASUREMENT, PROBLEM ISOLATED ON THE PCBA2. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A PILLOWING KEYPAD OVERLAY AND A SCRATCHED CASE. LOW BATTERY LIFE OR LOW BATTERY ALERT AND LOW BATTERY ALERT LESS THAN 1 WEEK CONFIRMED. LOW BATTERY LIFE OR LOW BATTERY ALERT AND LOW BATTERY ALERT LESS THAN 1 WEEK, PROBLEM ISOLATED ON THE PCBA2.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS RECEIVED LOW BATTERY ALERT AND SHORT BATTERY LIFE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705783 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 HG4XEHPZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female