BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1984369 · Received February 10, 2011

    Report

    Report Number
    2954323-2011-01580
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 14, 2011
    Report Date
    April 22, 2011
    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 (1002828) 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 WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: DATE OF THE EVENT IS UNKNOWN; THE DATE IN B3 IS THE DATE THE CUSTOMER REPORTED THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER'S FAMILY MEMBER REPORTED THE CUSTOMER EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA (DATE IS UNKNOWN) AND WHEN HE TESTED HIS BLOOD GLUCOSE, HE RECEIVED A READING OF 116 MG/DL ON HIS FREESTYLE LITE METER. THE CUSTOMER'S FAMILY MEMBER ALSO REPORTED THE CUSTOMER DID NOT EXPERIENCE LOSS OF CONSCIOUSNESS OR SEIZURE; HOWEVER, HE WAS DISORIENTED. THE PARAMEDICS WERE CALLED AND THEY TESTED THE CUSTOMER'S BLOOD GLUCOSE WITH THEIR DEVICE AND OBTAINED A READING OF 47 MG/DL. THE CUSTOMER WAS REPORTEDLY TREATED WITH GLUCOSE INTRAVENOUSLY AND TRANSPORTED TO THE LOCAL HOSPITAL. THE CUSTOMER WAS NOT ADMITTED, BUT STAYED IN THE HOSPITAL FOR APPROXIMATELY 5-6 HOURS. IT WAS ALSO REPORTED THE CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND HE DID NOT BELIEVE THE HOSPITAL GAVE HIM ANY MEDICATIONS; HOWEVER, THEY KEPT MONITORING HIS BLOOD GLUCOSE LEVEL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1002828

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention