BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    640G INSULIN PUMP MMT-1712K

    MDR report key: 13420177 · Received February 2, 2022

    Report

    Report Number
    2032227-2022-107960
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    July 23, 2021
    Report Date
    February 1, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000192143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = CLEAR. CUSTOMER RETURNED PUMP FOR AN CHARGE/BATTERY LASTS LESS THAN EXPECTED ON 07/23/2021. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE PUMP PASSED THE DISPLACEMENT TEST, ACTIVE CURRENT TEST, SLEEP CURRENT MEASUREMENT TEST AND SELF TEST. NO POWER LOSS ANOMALY NOTED DURING TESTING. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS TOOL. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WERE WITHIN SPEC RANGE. NO ALARMS OR ALERTS NOTED DURING TESTING, HOWEVER, LOW BATTERY ALERT (104)-07/23/2021 00:22:00.000, BATTERY REMOVED (84)-07/23/2021 01:04:16.000, BATT OUT LIMIT (6)-07/23/2021 18:52:21.000 AND FAILED BATT TEST (58)-07/23/2021 06:38:38.000 WERE FOUND IN THE HISTORY FILES. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CRACKED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED KEYPAD OVERLAY AND FADED SERIAL NUMBER LABEL. IN SUMMARY, CUSTOMER ALLEGED BATTERY LASTS LESS THAN EXPECTED NOT CONFIRMED. (B)(4). A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE 640G INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A REPLACE BATTERY ALARM. CUSTOMER STATED THAT BATTERY EMPTY AFTER 3 HOURS. 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
    1220545 640G INSULIN PUMP MMT-1712K PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1712K HG3KHWN 000000763000192143

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown