BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1979007 · Received February 4, 2011

    Report

    Report Number
    2954323-2011-01462
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 4, 2011
    Product Code
    NBW
    Removal / Correction Number
    ADC FA1197-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN USING AN AFFECTED TEST STRIP RELATED TO AN ON-GOING FIELD ACTION FOR ABBOTT PRECISION FAMILY TEST STRIPS, THE CUSTOMER REPORTED A READINGS ISSUE. AS A RESULT OF THIS ISSUE, THE CUSTOMER REPORTED EXPERIENCING BLURRED VISION, AND DOSED WITH INSULIN TO COUNTERACT SYMPTOMS. THERE WAS NO REPORT OF THIRD PARTY MEDICAL INTERVENTION, NO MEDICATION ADMINISTERED OUTSIDE OF THEIR NORMAL TREATMENT REGIMEN, NOR WAS THERE DIAGNOSIS OF HYPOGLYCEMIA, HYPERGLYCEMIA, OR ANY OTHER DIABETES RELATED CONDITION. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IN USING AN AFFECTED TEST STRIP RELATED TO AN ON-GOING FIELD ACTION FOR ABBOTT PRECISION FAMILY TEST STRIPS, THE CUSTOMER REPORTED EITHER LONGER BLOOD FILL TIME OR READINGS ISSUES. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW 45677

    Patients

    Seq Age Sex Outcome Treatment
    1