BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINESSE PATCH

    MDR report key: 4843817 · Received June 15, 2015

    Report

    Report Number
    3008272700-2015-00001
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Report Date
    June 5, 2015
    Manufacturer
    CALIBRA MEDICAL, INC
    Product Code
    LZG
    PMA / PMN Number
    K111924
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CALIBRA HAS BEEN UNABLE TO REQUEST RETURN OF THE PRODUCT AT THIS TIME. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON 06/05/2015, CALIBRA RECEIVED AN ANONYMOUS SURVEY WHICH INDICATED THAT ONE OF THE INSULIN DELIVERY PATCHES HAD STOPPED WORKING; THE PATIENT REPORTEDLY APPLIED A NEW PATCH AFTER THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED RELATED TO THE COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE REMAINED UNRESOLVED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389754 FINESSE PATCH FINESSE INSULIN DELIVERYSYSTEM LZG CALIBRA MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1