BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 8133143 · Received December 5, 2018

    Report

    Report Number
    2954323-2018-09309
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 15, 2018
    Report Date
    January 10, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    PMA / PMN Number
    K092602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW- UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: THE METER IS DESIGNED TO REPORT READINGS OF 20 MG/DL TO 500 MG/DL. IT SHOULD BE NOTED THAT THIS METER DOES NOT GIVE NUMERIC VALUE FOR READINGS LESS THAN 20 MG/DL. A "LO" DISPLAY MESSAGE INDICATES A READING LESS THAN 20 MG/DL. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: (STRIP LOT NUMBER) AND (EXPIRATION DATE) HAS BEEN UPDATED BASED ON THE RETURNED PRODUCT. THE REPORTED METER AND STRIP LOT NUMBER 1060316 HAVE BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED ON THE REPORTED METER AND NO ISSUES WERE OBSERVED. THE METER POWERED ON WITH BUTTON DEPRESSION AND WITH STRIP INSERTION. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE REPORTED READINGS WERE NOT FOUND IN THE METER'S MEMORY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 130 MG/DL, 20 MG/DL, 140 MG/DL AND 30 MG/DL WITHIN 10 MINUTES. 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

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 130 MG/DL, 20 MG/DL, 140 MG/DL AND 30 MG/DL WITHIN 10 MINUTES. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973083 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. 71501-01 1060316

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR