BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 13339545 · Received January 24, 2022

    Report

    Report Number
    2032227-2022-105532
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    September 20, 2021
    Report Date
    January 24, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000365882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER RETURNED PUMP FOR AN ALLEGED LOW BATTERY LIFE OR LOW BATTERY ALERT AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM 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 THUS. 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, LOW BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 23:12:00.000. (B)(6) 2021 18:11:00.000 TO (B)(6) 2021 22:24:00.000. (B)(6) 2021 11:41:00.000. (B)(6) 2021 08:25:00.000 TO (B)(6) 2021 22:52:50.000. INSERT BATTERY ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 08:30:18.000. (B)(6) 2021 22:15:52.000 TO (B)(6) 2021 22:20:08.000. (B)(6) 2021 08:06:33.000 TO (B)(6) 2021 21:21:19.000. (B)(6) 2021 07:52:20.000 TO (B)(6) 2021 23:06:08.000. POWER LOSS ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 11:40:12.000 TO (B)(6) 2021 21:32:28.000. (B)(6) 2021 08:19:22.000 TO (B)(6) 2021 23:06:40.000. REPLACE BATTERY ALERT WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 07:55:00.000 TO (B)(6) 2021 21:12:00.000. (B)(6) 2021 07:11:00.000 TO (B)(6) 2021 18:06:00.000. FAILED BATT/BATTERY FAILED ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 22:16:16.000. (B)(6) 2021 22:16:32.000. (B)(6) 2021 08:06:39.000 TO (B)(6) 2021 21:31:00.000. (B)(6) 2021 07:52:33.000 TO (B)(6) 2021 22:53:15.000. REPLACE BATTERY NOW ALARM WAS RECORDED AND FOUND IN THE FORMATTED HISTORY FILE ON: (B)(6) 2021 07:42:00.000 TO (B)(6) 2021 18:37:00.000. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND CORROSION ON THE PCB1 AND VIBRATOR ASSEMBLY. NO CORROSION OR MOISTURE DAMAGE WAS FOUND ON THE FORCE SENSOR AND MOTOR ASSEMBLY. THE ORIGINAL PCB1 WAS CLEANED AND INSTALLED IN A TEST PCB2, 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 PCB2 WAS INSTALLED IN A TEST PCB1, 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 DUE TO CORROSION ON THE PCB1. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: A MISSING DISPLAY WINDOW/COVER, A STAINED KEYPAD OVERLAY, A PILLOWING KEYPAD OVERLAY, A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE AND A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT. LOW BATTERY LIFE OR LOW BATTERY ALERT AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM WAS CONFIRMED. LOW BATTERY LIFE OR LOW BATTERY ALERT AND UNEXPECTED BATTERY POWER LOSS OR REPLACE BATTERY ALERT/REPLACE BATTERY NOW ALARM DUE TO CORROSION ON THE PCB1.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD REPLACE BATTERY ALARM. CUSTOMER STATED THEY RECEIVED LOW BATTERY ALERT PRIOR TO REPLACE BATTERY ALARM. CUSTOMER STATED TIMING WAS LESS THAN 8 HOURS FROM THE LOW BATTERY ALERT TO THE REPLACE BATTERY ALERT. CUSTOMER STATED IT WAS SECOND OCCURRENCE OF REPLACED BATTERY ALARM AFTER LOW BATTERY WARNING. 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
    1532687 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4E9VG 000000763000365882

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female