BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON CALL EXPRESS GLUCOSE METER

    MDR report key: 11060715 · Received December 22, 2020

    Report

    Report Number
    2531491-2020-00010
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    December 15, 2020
    Report Date
    December 21, 2020
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    NBW
    PMA / PMN Number
    K132086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACON WAS MADE AWARE OF THE COMPLAINT VIA CUSTOMER CALL ON (B)(6) 2020 REGARDING A POTENTIAL INACCURATE READINGS ON THE ON CALL EXPRESS BLOOD GLUCOSE METER (OCX). THE REPORTER OF THE COMPLAINT INFORMED ACON THAT THE PATIENT WAS HOSPITALIZED DUE TO INACCURATE READINGS IN BLOOD GLUCOSE VALUES ON THE OCX METER, WHICH LIKELY GIVEN A HIGHER VALUE THAN THE ACTUAL PATIENT CONDITION. AS PER THE REPORTER, THE MEASUREMENT OF BLOOD GLUCOSE VALUES IS LOWER WHEN THE PATIENT WAS MEASURED AT THE HOSPITAL. THE HIGHER READINGS MAY AFFECT INSULIN DOSAGE AND MAKES DETECTION OF HYPOGLYCEMIA DIFFICULT. NO FURTHER INFORMATION ABOUT PATIENT CONDITION WAS AVAILABLE AT THE TIME OF THE MDR. THE RETURN OF BOTH THE METER AND THE STRIP WILL BE REQUESTED FOR EVALUATION IN ADDITION TO THE RETENTION LOTS. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524120 ON CALL EXPRESS GLUCOSE METER GLUCOSE TEST SYSTEM NBW ACON LABORATORIES, INC. NI 1190712

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R