BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 8821320 · Received July 24, 2019

    Report

    Report Number
    2032227-2019-35401
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    July 15, 2019
    Report Date
    September 18, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000166526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE AT ELECTRONIC ASSEMBLY. DEVICE FOUND MOISTURE DAMAGE AT MOTOR ASSEMBLY NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT THE INSERT BATTERY ALARM WAS DISPLAYED ON THE INSULIN PUMP SCREEN. CUSTOMER STATES THE CONTACTS ON THE BATTERY CAP ARE NEITHER MISSING NOR DAMAGED, BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED AND THE SPRING WAS NEITHER DAMAGED NOR CORRODED. TROUBLE SHOOTING WAS PERFORMED FOR BLANK DISPLAY. CUSTOMER WAS ADVISED TO INSERT NEW AA BATTERY. DISPLAY DID NOT RETURN AFTER PUMP RESTART. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614293 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG3B53S 00763000166526

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR