BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1886328 · Received October 29, 2010

    Report

    Report Number
    2954323-2010-01498
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 29, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER ((B)(4) AND TEST STRIPS OF LOT # 1061013) WERE RETURNED FOR AN INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT THEIR FREESTYLE LITE BLOOD GLUCOSE METER WAS USED AT THE HOSPITAL TO DETERMINE THE BLOOD GLUCOSE LEVEL OF A NEWBORN PATIENT WHO WAS ALREADY IN THE HOSPITAL, AND THE READING OBTAINED ON THAT ADC METER WAS LOWER WHEN COMPARED TO A READING RECEIVED ON THEIR HEMOCUE DEVICE. AS A RESULT, THE NEWBORN PATIENT WAS REPORTEDLY MISTREATED WITH GLUCOSE 10 % INTRAVENOUS DRIP. THERE WAS NO REPORT OF SYMPTOMS, MEDICAL DIAGNOSIS, AND TREATMENT TO COUNTERACT THE EVENT. 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 1061013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other