BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2884026 · Received December 21, 2012

    Report

    Report Number
    2954323-2012-06782
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED METER (B)(4). THE RETURNED METER WAS INVESTIGATED WITH RETAINED TEST STRIPS (LOT 1185436). 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.

    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. THE ACTUAL DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. (B)(4) ADDITIONALLY: THE TEST STRIPS THE CUSTOMER WAS ATTEMPTING TO USE EXPIRED ON APRIL 30, 2012.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT APPROXIMATELY FOUR MONTHS PRIOR TO CALLING CUSTOMER SERVICE ON (B)(6), 2012 THE TEST DID NOT START ON HER ADC BLOOD GLUCOSE METER AFTER A SAMPLE WAS APPLIED TO A TEST STRIP INSERTED INTO IT. CUSTOMER FURTHER REPORTED THAT DUE TO THIS SHE COULD NOT TEST AND SUBSEQUENTLY EXPERIENCED A "FEVER", WAS "SWEATING" AND BECAME "DIZZY", RESULTING IN A "SEIZURE". CUSTOMER SELF-TREATED WITH METFORMIN 1000 MG, THEN SELF-PRESENTED TO HER HEALTHCARE PROVIDER, BUT DID NOT RECEIVE ANY DIAGNOSIS OR EMERGENT MEDICAL INTERVENTION. CUSTOMER WAS ADVISED TO INCREASE HER DAILY DOSE OF METFORMIN. 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 1079305

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other