BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2873129 · Received December 13, 2012

    Report

    Report Number
    2954323-2012-06767
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 18, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED METER WAS RETURNED AND INVESTIGATED WITH RETAINED TEST STRIPS. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY. GIVEN NO TEST STRIPS WERE RETURNED FOR INVESTIGATION, RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1263024) WERE TESTED WITH CONTROL SOLUTION. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2012 AT 7:00 AM SHE RECEIVED A READING OF 97 MG/DL ON HER ADC METER WHICH WAS LOWER THAT SHE FELT. CUSTOMER FURTHER REPORTED THAT AROUND 8 AM SHE STARTED TO EXPERIENCE SYMPTOMS THAT WERE DESCRIBED AS "NAUSEATED, HER CHEST AND STOMACH WERE ACHING, BLURRED VISION, DIZZY, LIGHTHEADED AND WEAK" AND CALLED PARAMEDICS. UPON ARRIVAL PARAMEDICS OBTAINED A BLOOD GLUCOSE READING OF 465 MG/DL ON AN UNKNOWN BRAND METER. MEDICAL SURVEY WAS NOT COMPLETED BECAUSE CUSTOMER DECLINED TO CONTINUE TROUBLESHOOTING. PRIOR TO DISCONNECTING THE PHONE CALL CUSTOMER STATED THAT SHE HAD SUSTAINED AN UNSPECIFIED INJURY. 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 1263024

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other