BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1840551 · Received September 21, 2010

    Report

    Report Number
    2954323-2010-01310
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 29, 2010
    Report Date
    October 21, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. 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. THE READING THE CUSTOMER REPORTED WAS FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER'S SON-IN-LAW REPORTED THAT ON (B)(6) 2010 CUSTOMER RECEIVED A READING OF 234 MG/DL ON HIS FREESTYLE LITE BLOOD GLUCOSE METER. IT WAS FURTHER REPORTED CUSTOMER BECAME UNRESPONSIVE, HAD SLURRED SPEECH, WAS UNABLE TO RECOGNIZE FAMILY MEMBERS AND HAD "NO MOTOR SKILLS". CUSTOMER WAS TAKEN BY FAMILY MEMBERS TO A LOCAL HEALTHCARE FACILITY WHERE A RESULT OF 30 MG/DL WAS OBTAINED ON AN UNKNOWN BRAND OF METER. CUSTOMER WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND REPORTEDLY TREATED WITH INSULIN. IT IS UNKNOWN HOW MUCH TIME HAD ELAPSED BETWEEN WHEN THE READING OF 234 MG/DL WAS RECEIVED AND THE READING OF 30 MG/DL. TWO UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER IN AN ATTEMPT TO CLARIFY THE TREATMENT THE CUSTOMER RECEIVED AND TIMEFRAME IN WHICH THE EVENT OCCURRED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE ARCHITECT C8000 ANALYZER GENERATED FALSELY ELEVATED CC CO2 AND ANION GAP RESULTS FOR MULTIPLE PATIENT SAMPLES. THE CUSTOMER RECALIBRATED THE CO2 ASSAY AND REPEATED THE SAMPLES, SOME OF WHICH REQUIRED CORRECT REPORTS. ONE PATIENT GENERATED AN INITIAL CO2 RESULT OF 37 MEQ/L WITH A REPEAT RESULT OF 25 MEQ/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1013130

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention