BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 12538996 · Received September 28, 2021

    Report

    Report Number
    2032227-2021-198806
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    June 28, 2021
    Report Date
    September 28, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. INSULIN PUMP POWERED UP PROPERLY AFTER BATTERY INSTALLATION. INSULIN PUMP PASSED DISPLACEMENT TEST PROPERLY. REVIEWED PUMP ALARM HISTORY WITHIN THE TIME FRAME OF THE COMPLAIN CALL AND NO RELEVANT ALARMS NOTED. PROCEED IT BY CUTTING INSULIN PUMP OPEN AND PERFORM A VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC STACK. PER VISION INSPECTION IT WAS DETERMINE THAT THE INGRESS OF WATER CAUSING CORROSION OF THE ELECTRONIC STACK, MOTOR ASSEMBLY AND KEYPAD CONNECTOR. INSULIN PUMP ALSO RECEIVED WITH CRACKED CASE(BATTERY TUBE).

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOISTURE DAMAGE. CUSTOMER STATED THAT THERE WAS FLUID IN 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
    1441574 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4FEMZ 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR