BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2772985 · Received October 4, 2012

    Report

    Report Number
    2954323-2012-06616
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 11, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN NO TEST STRIPS WERE RETURNED FOR INVESTIGATION, RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1181836) WERE TESTED WITH CONTROL SOLUTION. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE METER (B)(4) WAS RETURNED AND AN INVESTIGATION UTILIZING THE RETURNED METER, RETAINED TEST STRIPS (LOT 1183009) AND RETAINED CONTROL SOLUTION (LOT 1F3U02) HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE TEST STRIPS INVOLVED IN THE COMPLAINT (LOT 1181836) HAVE BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. (B)(4) ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SINCE JULY, WHEN HE STARTED TO USE THE METER, THE TEST DID NOT START ON HIS ADC BLOOD GLUCOSE METER AND HE HAD TO USE FIVE TEST STRIPS TO GET ONE READING. HE FURTHER REPORTED THAT DUE TO THIS, ON (B)(6), 2012 HE SAW "BLACK SPOTS FROM (HIS) EYES, ALMOST WENT INTO SHOCK" AND SUBSEQUENTLY EXPERIENCED A LOSS OF CONSCIOUSNESS. NO THIRD-PARTY MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER SELF-TREATED BY EATING CHOCOLATE. 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 1181836

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R