BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2721782 · Received August 30, 2012

    Report

    Report Number
    2954323-2012-06526
    Event Type
    Injury
    Date Received
    August 30, 2012
    Date of Event
    August 9, 2012
    Report Date
    August 9, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1253461) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. NOTE: CUSTOMER'S WEIGHT IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A READING OF 86 MG/DL ON HER ADC METER WHICH WAS LOWER THAN SHE FELT. MEDICAL SURVEY WAS NOT COMPLETED BECAUSE THE PHONE CALL WAS DISCONNECTED AND MULTIPLE ATTEMPTS BY CUSTOMER SERVICE TO REACH CUSTOMER TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IT WAS REPORTED THAT CUSTOMER EXPERIENCED UNKNOWN INJURY RELATED TO THE REPORTED ISSUE. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1253461

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other