BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINX IO CT/NG ASSAY

    MDR report key: 16856854 · Received May 2, 2023

    Report

    Report Number
    3017907743-2023-00001
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    February 9, 2023
    Report Date
    May 2, 2023
    Manufacturer
    BINX HEALTH LTD.
    Product Code
    QEP
    UDI-DI
    05060441760050
    PMA / PMN Number
    K200533
    Removal / Correction Number
    3017812966-3/29/23-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE BINX IO CT/NG CARTRIDGE, WHEN TESTED USING THE BINX IO INSTRUMENT, IS A FULLY AUTOMATED, RAPID, QUALITATIVE TEST INTENDED FOR USE IN POINT-OF-CARE OR CLINICAL LABORATORY SETTINGS FOR THE DETECTION OF CHLAMYDIA TRACHOMATIS (CT) AND NEISSERIA GONORRHOEAE (NG) DNA BY POLYMERASE CHAIN REACTION. LOT 00210869309 OF THE BINX IO CT/NG CARTRIDGES FAILED ITS FINISHED PRODUCT QUALITY CONTROL (QC) TESTING. LOT 00210869309 WAS QUARANTINED ON 13 JULY 2022 AND NO DEVICES FROM THIS LOT WERE TO BE DISTRIBUTED TO CUSTOMERS. LOT 00210869309 WAS INTENDED FOR INTERNAL USE ONLY BY BINX HEALTH FIELD SERVICE EMPLOYEES FOR PERFORMING TEST ASSESSMENTS. A PROCESSING ERROR BY A THIRD-PARTY LOGISTICS PROVIDER MEANT THAT ONE BOX OF LOT 00210869309 PRODUCT WAS INADVERTENTLY ALLOCATED TO A CUSTOMER ORDER AND SHIPPED TO A SINGLE SITE ON 09 FEBRUARY 2023. ONE BOX EQUALS FIFTY CT/NG CARTRIDGES. THE PROCESSING ERROR WAS IDENTIFIED DURING AN INTERNAL INVENTORY RECONCILIATION ON 14 MARCH 2023. INFORMATION REGARDING PATIENT OUTCOMES BASED ON PATIENT SAMPLES RUN USING THE CT/NG CARTRIDGES FROM LOT 00210869309 HAS NOT BEEN SHARED WITH BINX HEALTH AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818883 BINX IO CT/NG ASSAY CT/NG ASSAY QEP BINX HEALTH LTD. 1.002.101 00210869309 05060441760050

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown