BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINX IO CT/NG ASSAY AND BINX IO CT/NG SYSTEM

    MDR report key: 20322499 · Received September 27, 2024

    Report

    Report Number
    3017907743-2024-00001
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 22, 2024
    Report Date
    October 29, 2024
    Manufacturer
    BINX HEALTH, LTD.
    Product Code
    QEP
    PMA / PMN Number
    K200533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BINX HEALTH RECEIVED LIMITED INFORMATION FROM A PROSPECTIVE CLIENT USING OUR DEVICE THAT A PATIENT "SPILLED SOME COLLECTION MATERIAL ON HER SKIN AND HAS A SEVERE BURN." THE MESSAGE INCLUDED A REQUEST FOR BINX TO PAY FOR THE PATIENT'S MEDICAL EXPENSES, SO IT APPEARS THAT MEDICAL INTERVENTION OCCURRED, THOUGH WE DO NOT YET KNOW WHAT MEDICAL INTERVENTION WAS PERFORMED. THE BINX IO CT/NG ASSAY AND BINX IO CT/NG SYSTEM CONSISTS OF THE FOLLOWING COMPONENTS: (1) THE BINX IO CT/NG CARTRIDGE (THE "CARTRIDGE") THAT CONTAINS ALL THE NECESSARY REAGENTS TO PERFORM THE BINX IO CT/NG ASSAY (THE "ASSAY") ON THE BINX IO INSTRUMENT (THE "INSTRUMENT") (2) THE BINX IO INSTRUMENT FOR RUNNING THE CARTRIDGE (3) A SINGLE-USE, FIXED-VOLUME TRANSFER PIPET (PACKAGED WITH THE CARTRIDGE) FOR TRANSFERRING THE SAMPLE TO THE CARTRIDGE (4) A MALE URINE COLLECTION KIT CONSISTING OF SAMPLE COLLECTION TUBE CONTAINING PRESERVATION MEDIUM AND A TRANSFER PIPET (THE "MALE URINE COLLECTION KIT") (5) A VAGINAL SWAB SPECIMEN COLLECTION KIT CONSISTING OF SAMPLE COLLECTION TUBE CONTAINING PRESERVATION MEDIUM AND A SAMPLE COLLECTION SWAB WITH A FLOCKED TIP (THE "SWAB COLLECTION KIT") BASED ON THE INFORMATION PROVIDED, THE PRESERVATION MATERIAL (EITHER BEFORE OR AFTER THE SAMPLE ADDITION) IN THE SWAB COLLECTION KIT IS PRESUMED TO BE THE COMPONENT THAT SPILLED ON THE PATIENT'S SKIN. BINX HEALTH HAS ATTEMPTED SEVERAL TIMES TO GET ADDITIONAL INFORMATION ON THE EXTENT OF THE PATIENT'S INJURY AND MEDICAL TREATMENT THAT WAS PROVIDED. WE HAVE NOT YET RECEIVED PATIENT IDENTIFIERS, DEMOGRAPHIC INFORMATION, OR TREATMENT INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 07 OCTOBER 2024: MEDIA SPILLED ON PATIENT'S LEG WHILE PERFORMING SELF-COLLECTION. THERE IS NO INFORMATION ON ANY IMMEDIATE FIRST AID PROVIDED WHEN THE SPILL WAS REPORTED AT THE PHARMACY, AND THERE IS NO EVIDENCE THAT THE PATIENT COMPLAINED OF PAIN OR DISCOMFORT AT THE TIME OF THE EVENT. THE PATIENT CALLED THE PHARMACY ON (B)(6) 2024 AND NOTIFIED THEM OF A SEVERE BURN. THE PHARMACIST INSTRUCTED THE PATIENT TO GO TO THE EMERGENCY ROOM FOR TREATMENT, WHERE SHE WAS GIVEN ANTIBIOTICS. LIFE WELL PHARMACY INFORMED BINX HEALTH OF THE EVENT ON 29 AUGUST 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371886 BINX IO CT/NG ASSAY AND BINX IO CT/NG SYSTEM NO MATCH QEP BINX HEALTH, LTD. 240278800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other