BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE NEO OPTIUM

    MDR report key: 9475809 · Received December 16, 2019

    Report

    Report Number
    2954323-2019-09888
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    November 25, 2019
    Report Date
    December 16, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K142928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED BACK AS THIS COMPLAINT WAS NOTED THROUGH A LITERATURE REVIEW. THE ACTUAL DATE WHEN THE EVENT OCCURRED IS UNKNOWN. THE DATE LISTED IS AN APPROXIMATION BASED UPON THE DETAILS IN THE CASE. THE SERIAL NUMBERS OF THE DEVICES ARE UNKNOWN; HENCE THE DATE OF MANUFACTURE IS UNKNOWN. THE DATE LISTED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THE REVIEW. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THROUGH THE LITERATURE REVIEW PROCESS, ABBOTT DIABETES CARE BECAME AWARE OF AN ARTICLE BY MARIAROSA CARTA, DAVIDE GIAVARINA, ANDREINA PATERNOSTER, AND GRAZIELLA BONETTI E ACCURACY OF GLUCOSE METERS IS EVALUATED BY COMPARING THEIR RESULTS WITH THOSE FROM A REFERENCE LABORATORY GLUCOSE ANALYSER. THE FOOD AND DRUG ADMINISTRATION (FDA) 2016 CRITERIA STATE THAT 95% OF GLUCOSE VALUES MUST BE WITHIN 15% OF REFERENCE AND 99% OF GLUCOSE VALUES MUST BE WITHIN 20% OF REFERENCE (6)WITH THE PRIMARY RECOMMEND THE USE OF A PROMPT GLYCOLYSIS INHIBITOR SUCH AS CITRATE FOR AN ACCURATE GLUCOSE DETERMINATION, THE STUDY LOOKED AT CAPILLARY AND PLASMA GLUCOSE MEASURED CONCENTRATIONS, DETERMINED IN TWO ITALIAN CLINICAL LABORATORIES, USING TUBES CONTAINING AN NAF AND CITRATE MIXTURE IN LIQUID AND GRANULAR FORM. REFERENCE P-GLUCOSE WAS DETERMINED WITH A HEXOKINASE METHOD ON DIMENSION VISTA SYSTEMS. DIFFERENCES BETWEEN CAPILLARY AND REFERENCE P-GLUCOSE WERE EVALUATED ACCORDING TO ADA/ISO 15197:2013 SPECIFICATIONS. THE ABBOTT FREESTYLE PRECISION NEO WAS USED TO DETERMINE BASAL CAPILLARY GLUCOSE IN BRESCIA (N=63), WHILE CLINICAL LABORATORY REFERENCE P-GLUCOSE WAS DETERMINED USING TUBES CONTAINING NAF/K3EDTA AND LIQUID NAF/NA2EDTA/CITRATE. ONLY 73.02% OF CAPILLARY GLUCOSE DETERMINATIONS WERE WITHIN ADA ¿ ISO 15197:2013 CRITERIA WHEN NAF/K3EDTA AND NAF/K2OX WERE USED. CONVERSELY, 96.82% OF CAPILLARY GLUCOSE DETERMINATIONS WERE WITHIN ADA¿ISO 15197:2013 CRITERIA WHEN LIQUID AND GRANULAR CITRATE MIXTURE TUBES. THERE WAS NO REPORT OF ANY THIRD-PARTY MEDICAL INTERVENTION OR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268864 FREESTYLE NEO OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 75175-84

    Patients

    Seq Age Sex Outcome Treatment
    1