BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 3090308 · Received May 2, 2013

    Report

    Report Number
    2954323-2013-00250
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECT BRAND NAME IS FREESTYLE FREEDOM LITE. (B)(4).

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1281905) 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

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE ACTUAL DATE OF THE REPORTED MEDICAL EVENT IS UNKNOWN. ADDITIONALLY: MULTIPLE, UNSUCCESSFUL, ATTEMPTS HAVE BEEN MADE TO CLARIFY DETAILS IN THIS COMPLAINT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CALLER (CUSTOMER'S MOTHER) REPORTED OBTAINING UNSPECIFIED READINGS ON THE ADC BLOOD GLUCOSE METER WHICH SHE PERCEIVED TO BE LOW. CALLER FURTHER REPORTED THE CUSTOMER EXPERIENCED "HIGH BLOOD SUGAR". THERE WAS NO REPORT OF SELF-TREATMENT. CUSTOMER WAS SEEN BY A HEALTH CARE PROFESSIONAL AND DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) AND "HIGH BLOOD SUGAR". CUSTOMER WAS TREATED WITH INSULIN VIA INTRAVENOUS INFUSION AND REMAINED HOSPITALIZED FOR TWO DAYS. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191944 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1281905

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R