BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE OPTIUM NEO

    MDR report key: 4241821 · Received November 10, 2014

    Report

    Report Number
    2954323-2014-01105
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K140371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. NO INVESTIGATION WILL BE UNDERTAKEN BECAUSE CUSTOMER WAS USING INCOMPATIBLE TEST STRIPS AND IT HAS PREVIOUSLY BEEN ESTABLISHED THAT THESE TEST STRIPS WILL PRODUCE LOWER RESULTS. NOTE: THE FREESTYLE NEO RELATED TO THIS REPORT IS BEING SUBMITTED FOR PURPOSES RELATED TO SAME AND SIMILAR REPORTING. THIS PRODUCT HAS NOT BEEN DISTRIBUTED FOR USE IN THE US. NOTE: THE DATE OF EVENT IS UNKNOWN. NOTE: THE SERIAL NUMBER OF THE METER INVOLVED IN THE COMPLAINT IS UNKNOWN; HENCE THE DEVICE MANUFACTURER DATE IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    AN ADC SALES REPRESENTATIVE FORWARDED THE FOLLOWING INFORMATION: CUSTOMER REPORTED SHE HAD BEEN USING HER FREESTYLE NEO BLOOD GLUCOSE METER FOR SEVERAL MONTHS WITH ONETOUCH VITA (LIFESCAN) TEST STRIPS AND HAD BEEN RECEIVING UNSPECIFIED "ANOMALOUS" RESULTS. CUSTOMER FURTHER REPORTED SHE HAD HER HGBA1C TEST DONE AND IT WAS NOTED TO BE 12%. CUSTOMER WAS HOSPITALIZED. IT IS UNKNOWN WHAT TREATMENT MAY HAVE BEEN RENDERED DURING HER HOSPITALIZATION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724070 FREESTYLE OPTIUM NEO BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization