BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1122844 · Received January 14, 2011

    Report

    Report Number
    2954323-2008-02414
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    July 23, 2008
    Report Date
    November 2, 2010
    Manufacturer
    ABBOTT DIABETES CARE INC,
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE INITIAL REPORT IN 2008, THE METER REPORTED HAD AN UNKNOWN SERIAL NUMBER AND WAS REPORTED TO BE A FS FREEDOM METER. A FS FREEDOM LITE METER WITH (B)(4) HAS BEEN RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL CONTROL SOLUTION TESTING RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE READINGS THE CUSTOMER REPORTED WERE NOT FOUND IN METER MEMORY. IT IS ALSO IMPORTANT TO NOTE THAT THE FIRST READING RECORDED WITHIN THE METER LOG WAS OBTAINED ON (B)(6) 2010. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE DEVICE HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HIS FREESTYLE FREEDOM BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 282 MG/DL, 120 MG/DL 113 MG/DL, 95 MG/DL AND 87 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW CREATININE RESULTS GENERATED ON THE SYNCHRON LX 20 CLINICAL SYSTEM. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS RERUN ON MODULAR CHEMISTRY (MC) AND HIGHER RESULT WAS OBTAINED. THE HIGHER RESULT WAS VERIFIED BY TESTING THE SAMPLE ON THE CARTRIDGE CHEMISTRY (CC). NO INFORMATION IS AVAILABLE IN REGARDS TO WHETHER OR NOT TREATMENT WAS INITIATED OR WITHHELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC, NI 0735504

    Patients

    Seq Age Sex Outcome Treatment
    1 NI