BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LIBRE

    MDR report key: 10826709 · Received November 11, 2020

    Report

    Report Number
    2954323-2020-10458
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    October 27, 2020
    Report Date
    November 11, 2020
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. AN 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 LIBRE SENSORS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. STABILITY DATA FOR LIBRE SENSORS WAS REVIEWED AND SHOWED NO ANOMALIES OR NON-CONFORMANCES THAT COULD HAVE LEAD TO THE COMPLAINT. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND FS LIBRE SENSORS, NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. THE DATE OF EVENT IS UNKNOWN. THE DATE IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE 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 PUBLISHED BY, (B)(6) & (B)(6) ON (B)(6) 2020. THE ARTICLE IS TITLED, "FLASH GLUCOSE MONITORING IN TYPE 1 DIABETES: A COMPARISON WITH SELF-MONITORING BLOOD GLUCOSE". THE ARTICLE CLARIFIES THE RELATIONSHIP BETWEEN FLASH GLUCOSE MONITORING FGM AND SELF-MONITORING BLOOD GLUCOSE (SMBG) VALUES, WE COMPARED THE TWO VALUES AFTER SIMULTANEOUS MEASUREMENT IN JAPANESE PATIENTS WITH TYPE 1 DIABETES, UNDER DAILY LIFE SETTINGS. A TOTAL OF 20 OUTPATIENTS WITH TYPE 1 DIABETES WERE ANALYZED. WHEN FGM AND SMBG WERE CARRIED OUT SIMULTANEOUSLY (WITHIN ¿3 MIN), THE VALUES WERE ADOPTED AND EACH FGM VALUE WAS MATCHED AND COMPARED WITH THE CORRESPONDING SMBG VALUE. IN ADDITION, WE ANALYZED OTHER CASES OF SIMULTANEITY DEFINED AS ¿WITHIN ¿2 MIN,¿ ¿WITHIN ¿1 MIN¿ AND ¿AT THE EXACT SAME TIME.¿ THE PERCENTAGE OF SMBG AND FGM VALUES IN THE CLINICALLY ACCEPTABLE ZONE A + B IN CLARKE AND CONSENSUS ERROR GRID ANALYSES WERE 97.9 AND 99.2%, RESPECTIVELY. FGM VALUES WERE LOWER THAN SMBG VALUES IN THE LOWER GLUCOSE RANGE, AND HIGHER IN THE HIGHER GLUCOSE RANGE. THE SHORTER THE TIME LAG BETWEEN MEASUREMENTS, THE HIGHER THE RATE OF CONCORDANCE BETWEEN FGM AND SMBG VALUES. WHILE THE LITERATURE REPORTED THE VALUES DID NOT CONFORM TO ISO: 15197:2013 CRITERIA, THE ENVIRONMENT OF THE TEST PARTICIPATES WERE PERFORMED IN ¿DAILY LIFE SETTINGS,¿ AND NOT IN AN ENVIRONMENT WHICH MAY OR MAY NOT BE, CONTROLLED IN THE ISO 15197:2013 CRITERIA. IN CONCLUSION, , IF AN ABNORMAL GLUCOSE IS DETECTED BY FGM, SBMG SHOULD THEN BE USED TO CONFIRM THE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286221 FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71938-01

    Patients

    Seq Age Sex Outcome Treatment
    1