BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1994161 · Received February 16, 2011

    Report

    Report Number
    2954323-2011-01673
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 4, 2011
    Report Date
    April 5, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ((B)(4)) WAS RETURNED AND AN INVESTIGATION UTILIZING RETAINED TEST STRIP (LOT NO: 1017514) AND RETAINED CONTROL SOLUTION (LOT NO: 0F3U01) HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: DURING THE TROUBLESHOOTING SURVEY IT WAS IDENTIFIED BY ADC CUSTOMER SERVICE THAT THE CUSTOMER APPLIED A SECOND SAMPLE OF BLOOD AFTER THE ALLOWED TIME. ADC CUSTOMER SERVICE EDUCATED THE CUSTOMER ON THE PROPER TECHNIQUE AND THE CUSTOMER WAS ABLE TO SUCCESSFULLY PERFORM A CONTROL SOLUTION TEST WITH NO ERROR MESSAGES.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED SHE RECEIVED AN ERROR-3 DISPLAY MESSAGE ON HER FREESTYLE LITE BLOOD GLUCOSE METER WHEN THE TEST STRIP WAS INSERTED INTO PORT AND WHEN A SAMPLE WAS APPLIED TO THE TEST STRIP. AS A RESULT OF THE ERROR MESSAGE, THE CUSTOMER REPORTED SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING AND EXPERIENCED LOSS OF CONSCIOUSNESS AS WELL AS BRUISING. THE DATE OF THE MEDICAL EVENT WAS (B)(6) 2011. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED AND NO MEDICATIONS WERE REPORTEDLY TAKEN TO COUNTERACT THE EVENT. THE CUSTOMER REPORTED SHE DRANK MILK. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1016730

    Patients

    Seq Age Sex Outcome Treatment
    1 Other