BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1509481 · Received October 16, 2009

    Report

    Report Number
    2954323-2009-01876
    Event Type
    Injury
    Date Received
    October 16, 2009
    Date of Event
    September 22, 2009
    Report Date
    July 11, 2011
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER ON FOLLOW-UP #1 SHOULD HAVE REFLECTED THE DATE OF (B)(6) 2010. AS PER THE ARRANGEMENTS DISCUSSED WITH (B)(4) FDA, THIS MDR IS BEING SUBMITTED FOR CORRECTION AS EXPLAINED TO THE AGENCY IN A (B)(4) 2011 LETTER ADDRESSED TO (B)(4).

    Additional Manufacturer Narrative · 1

    AS NO PRODUCT WAS RETURNED, RETAIN TESTING OF STRIP LOT 0913913 WAS PERFORMED AND TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC GLUCOSE READINGS OF 178 MG/DL, 190 MG/DL AND 220 MG/DL FROM HIS FREESTYLE LITE METER. CUSTOMER ALSO REPORTED EXPERIENCING SYMPTOMS OF CALMNESS, DISORIENTATION AND LOSS OF CONSCIOUSNESS. CUSTOMER STATED THAT HE WAS BEING DIAGNOSED WITH SEVERE HYPOGLYCEMIA AT A HEALTH CARE FACILITY AND TREATED WITH JUICE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 262 MG/DL AND 96 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC, USA NA 0913913

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization