BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1904725 · Received November 22, 2010

    Report

    Report Number
    2954323-2010-01575
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    September 8, 2010
    Report Date
    February 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 (0935633) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2010 AT APPROXIMATELY 6:00 PM, SHE RECEIVED A READING OF 459 MG/DL ON HER FREESTYLE LITE BLOOD GLUCOSE METER. CUSTOMER NOTED, SHE DID NOT EXPERIENCE ANY SYMPTOMS AND WAS FEELING "FINE", BUT WAS ADVISED BY A NURSE TO GO TO THE HOSPITAL. CUSTOMER SELF-PRESENTED TO A LOCAL HEALTHCARE FACILITY APPROXIMATELY 30 MINUTES LATER, WHERE A READING OF 76 MG/DL WAS RECEIVED ON AN UNKNOWN BRAND OF METER. CUSTOMER RECEIVED NO DIAGNOSIS, BUT WAS GIVEN AN INTRAVENOUS INFUSION OF UNKNOWN TYPE, IN ADDITION TO BEING GIVEN JUICE TO DRINK. APPROXIMATELY TWO HOURS LATER, ANOTHER BLOOD GLUCOSE READING WAS OBTAINED WITH A RESULT OF 98 MG/DL AND THE CUSTOMER WAS DISCHARGED FROM THE HOSPITAL. 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 0935633

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention