BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON CALL EXPRESS BLOOD GLUCOSE METER

    MDR report key: 15921265 · Received December 5, 2022

    Report

    Report Number
    2531491-2022-00014
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    November 18, 2022
    Report Date
    March 7, 2023
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    NBW
    PMA / PMN Number
    K132086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS FOLLOW-UP REPORT, THE FOLLOWING INFORMATION HAS BEEN UPDATED FROM THE INITIAL REPORT UPON COMPLETION OF THE INTERNAL INVESTIGATION. B4, "DATE OF THIS REPORT" - UPDATED "DATE OF THIS REPORT" TO THE DATE OF SUBMITTAL OF THE FOLLOW-UP REPORT G6, "TYPE OF REPORT" - FOLLOW-UP # 1. H2, "IF FOLLOW-UP, WHAT TYPE?" - UPDATED TO "ADDITIONAL INFORMATION" AND/OR "DEVICE EVALUATION". H6 "ADVERSE EVENT PROBLEM" - "INVESTIGATION FINDINGS" AND "INVESTIGATION CONCLUSIONS" ARE ADDED PER INVESTIGATION. H10 "ADDITIONAL NARRATIVE/DATA" - ADDED MANUFACTURER'S NARRATIVE:

    Description of Event or Problem · 0

    ACON WAS MADE AWARE OF THE COMPLAINT VIA CUSTOMER CALL ON NOV 18, 2022 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 CONCENTRATION. AS PER THE REPORT, THE MEASUREMENT OF BLOOD GLUCOSE VALUES IS LOWER WHEN THE PATIENT WAS MEASURED BY EMTS. THE HIGHER READINGS MAY AFFECT INSULIN DOSAGE AND MAKES DETECTION OF HYPOGLYCEMIA DIFFICULT. THE PATIENT HAS SINCE RECOVERED AT THE TIME OF THE MDR. THE RETURN OF ALL TESTING MATERIALS INCLUDING METER/STRIPS/CONTROL SOLUTIONS WILL BE REQUESTED FOR EVALUATION IN ADDITION TO THE RETENTION LOTS. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACON WAS MADE AWARE OF THE COMPLAINT VIA CUSTOMER CALL ON NOV 18, 2022 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 CONCENTRATION. AS PER THE REPORT, THE MEASUREMENT OF BLOOD GLUCOSE VALUES IS LOWER WHEN THE PATIENT WAS MEASURED BY EMTS. THE HIGHER READINGS MAY AFFECT INSULIN DOSAGE AND MAKES DETECTION OF HYPOGLYCEMIA DIFFICULT. THE PATIENT HAS SINCE RECOVERED AT THE TIME OF THE MDR. THE RETURN OF ALL TESTING MATERIALS INCLUDING METER/STRIPS/CONTROL SOLUTIONS 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
    1946124 ON CALL EXPRESS BLOOD GLUCOSE METER GLUCOSE TEST SYSTEM NBW ACON LABORATORIES, INC. NI STRIP: 1191013, CTRL: RL80072

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R