BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE

    MDR report key: 690419 · Received March 17, 2006

    Report

    Report Number
    1826988-2006-00240
    Event Type
    Malfunction
    Date Received
    March 17, 2006
    Date of Event
    March 10, 2006
    Report Date
    March 10, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    CGA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS RECEIVING ERRATIC READINGS. WITHIN A TEN MIN PERIOD, SHE HAD THE FOLLOWING RESULTS: 243, 111, 245, 110, AND 149 MG/DL. THE CUSTOMER TOOK BOTH BLOOD AND CONTROL TESTS, SHE WAS NOT SURE WHICH RESULTS WERE BLOOD TESTS AND AND WHICH RESULTS WERE CONTROL TESTS. CUSTOMER SVC STATED THAT ALL CONTROL TESTS IN THE MEMORY OF THE METER WERE OUT OF THE CONTROL RANGE OF 116-167 MG/DL. THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS BASED ON THE ERRATIC READINGS. THE STRIPS ARE TO RETURNED FOR EVALUATION, AND REPLACEMENT STRIPS ARE TO BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE BLOOD GLUCOSE METER CGA BAYER HEALTHCARE, LLC 6117 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN