BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2072204 · Received April 28, 2011

    Report

    Report Number
    2954323-2011-03089
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 9, 2011
    Report Date
    June 24, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ADDITIONALLY: THE SERIAL NUMBER OF THE METER IS UNKNOWN; THEREFORE, THE DATE OF MANUFACTURE IS ALSO UNKNOWN. THE DATE LISTED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1156842) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    A CUSTOMER CALLED CUSTOMER SERVICE ON (B)(6) 2011 TO REQUEST TRAINING IN APPLYING A SAMPLE TO A TEST STRIP IN USE WITH HER FREESTYLE LITE BLOOD GLUCOSE METER. AFTER THE TRAINING WAS PROVIDED CUSTOMER REPORTED THAT HER METER WAS NOT GIVING HER ACCURATE RESULTS (NO READINGS WERE PROVIDED) AND NOTED BECAUSE OF THIS SHE WAS "FREESTYLING" WITH HER INSULIN. SHE FURTHER REPORTED ENGAGING THE SERVICES OF A HOSPITAL, REPLYING "YES" WHEN ASKED IF SHE HAD SUSTAINED AN INJURY AS A RESULT, BUT REFUSED TO PROVIDE ANY FURTHER INFORMATION. CUSTOMER DECLINED TO PROVIDE HER NAME AND CONTACT INFORMATION, SO NO ADDITIONAL INFORMATION CAN BE OBTAINED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1156842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other