BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON CALL EXPRESS BLOOD GLUCOSE METER

    MDR report key: 18640484 · Received February 5, 2024

    Report

    Report Number
    2531491-2024-00010
    Event Type
    Injury
    Date Received
    February 5, 2024
    Date of Event
    January 17, 2024
    Report Date
    February 2, 2024
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    NBW
    PMA / PMN Number
    K132086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ACON WAS MADE AWARE OF THE COMPLAINT VIA CUSTOMER CALL ON JAN 17, 2024 REGARDING ACCIDENTAL INGESTION OF DESICCANT MATERIAL FROM THE REAGENT VIAL OF THE ON CALL EXPRESS (OCX) BLOOD GLUCOSE STRIP. THE CUSTOMER (REPORTER OF THE COMPLAINT) INFORMED ACON THAT THE INCIDENT PRODUCED MINOR SYMPTOMS DUE TO THE ACCIDENTAL INGESTION FROM THE OCX STRIP VIAL. THE INCIDENT WAS ATTRIBUTED TO CUSTOMER NOT FOLLOWING INTENDED USE OF THE DEVICE (I.E., USING THE REAGENT VIAL AS DRUG STORAGE CONTAINER). AS PER THE REPORT, THE ACCIDENTAL INGESTION DID NOT PRODUCE LONG TERM EFFECT, AND THE CUSTOMER HAS SINCE RECOVERED WHEN S/HE CONTACTED ACON. THE INCIDENT WILL BE RECORDED AND TRACKED INTERNALLY FOR ACON RECORDS. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288912 ON CALL EXPRESS BLOOD GLUCOSE METER GLUCOSE TEST SYSTEM NBW ACON LABORATORIES, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other