BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 10929188 · Received December 1, 2020

    Report

    Report Number
    2954323-2020-12418
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    November 4, 2020
    Report Date
    December 1, 2020
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    NBW
    UDI-DI
    00699073710260
    PMA / PMN Number
    K092602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED METER (B)(4) AND TEST STRIPS 1072093 HAVE BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION HAS BEEN PERFORMED AND NO ISSUES WERE OBSERVED. METER POWERED ON WITH BUTTON DEPRESSION AND WITH STRIP INSERTION. CONTROL SOLUTION TESTING HAS BEEN PERFORMED AND NO ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION. NO MALFUNCTION OR PRODUCT DEFICIENCIES WERE OBSERVED. EXTENDED INVESTIGATION HAS ALSO BEEN PERFORMED AND IT WAS DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS FOR THE FREESTYLE LITE METER WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE LITE METER PASSED ALL TESTS PRIOR TO RELEASE. DHRS FOR THE FREESTYLE TEST STRIPS WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE TEST STRIPS PASSED ALL TESTS PRIOR TO RELEASE. RETAIN TESTING WAS PERFORMED FOR THE FREESTYLE STRIPS AND ALL UNITS PERFORMED WITHIN SPECIFICATION. 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 13 MG/DL AND 130 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
    1390049 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC 70805-70 1072093 00699073710260

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR