BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE INSULINX

    MDR report key: 8608739 · Received May 14, 2019

    Report

    Report Number
    2954323-2019-03871
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    April 15, 2019
    Report Date
    December 16, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    PMA / PMN Number
    K120568
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. CLINICAL DATA WAS REVIEWED AND CONFIRMED THAT FREESTYLE STRIPS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. STABILITY DATA FOR FREESTYLE STRIPS WAS REVIEWED AND SHOWED NO ANOMALIES OR NON-CONFORMANCES THAT COULD HAVE LED TO THE COMPLAINT. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND FREESTYLE INSULINX METER, NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND FREESTYLE STRIPS, NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED, AND A PHYSICAL INVESTIGATION WILL BE PERFORMED

    Description of Event or Problem · 0

    ABBOTT DIABETES CARE BECAME AWARE OF AN ARTICLE BY N. JENDRIKE, ET AL TITLED, ¿EVALUATION OF FOUR BLOOD GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING WITH BUILT-IN INSULIN DOSE ADVISOR BASED ON ISO 15197:2013: SYSTEM ACCURACY AND HEMATOCRIT INFLUENCE¿, PUBLISHED IN DIABETES TECHNOLOGY AND THERAPEUTICS, VOLUME 20, (B)(6) 2018. THE ARTICLE REPORTED THE RESULTS OF A CLINICAL TRIAL CONDUCTED FROM JANUARY TO FEBRUARY 2016, INVOLVING FOUR DIFFERENT SMBG SYSTEMS; INCLUDING ABBOTT DIABETES CARE¿S FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM. THE TRIAL INCLUDED A TOTAL OF 123 STUDY PARTICIPANTS, OF WHICH 12 SUBJECTS WERE INCLUDED IN THIS PART OF THE STUDY. THE RESULTS OF THE CLINICAL TRIAL NOTED THAT THIS METER DID NOT FULFILL THE ISO REGULATION DUE TO HEMATOCRIT INFLUENCES OUTSIDE OF THE DEFINED PARAMETERS. 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.

    Additional Manufacturer Narrative · 1

    THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED. A FOLLOW-UP REPORT WILL BE FILED IF PRODUCT IS RETURNED OR ADDITIONAL INFORMATION IS OBTAINED. 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 EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ABBOTT DIABETES CARE BECAME AWARE OF AN ARTICLE BY N. JENDRIKE, ET AL TITLED, ¿EVALUATION OF FOUR BLOOD GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING WITH BUILT-IN INSULIN DOSE ADVISOR BASED ON ISO 15197:2013: SYSTEM ACCURACY AND HEMATOCRIT INFLUENCE¿, PUBLISHED IN DIABETES TECHNOLOGY AND THERAPEUTICS, VOLUME 20, NUMBER 4, 2018. THE ARTICLE REPORTED THE RESULTS OF A CLINICAL TRIAL CONDUCTED FROM JANUARY TO FEBRUARY 2016, INVOLVING FOUR DIFFERENT SMBG SYSTEMS; INCLUDING ABBOTT DIABETES CARE¿S FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM. THE TRIAL INCLUDED A TOTAL OF 123 STUDY PARTICIPANTS, OF WHICH 12 SUBJECTS WERE INCLUDED IN THIS PART OF THE STUDY. THE RESULTS OF THE CLINICAL TRIAL NOTED THAT THIS METER DID NOT FULFILL THE ISO REGULATION DUE TO HEMATOCRIT INFLUENCES OUTSIDE OF THE DEFINED PARAMETERS. 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
    400260 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 71143-70

    Patients

    Seq Age Sex Outcome Treatment
    1