BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORAQUICK ADVANCE RAPID HIV-1/2 TEST

    MDR report key: 11515975 · Received March 18, 2021

    Report

    Report Number
    3004142665-2021-00002
    Event Type
    Injury
    Date Received
    March 18, 2021
    Date of Event
    March 16, 2018
    Report Date
    March 18, 2021
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    MTK
    UDI-DI
    00608337000887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN E-MAIL WAS RECEIVED FROM THE CUSTOMER WHO REPORTED THE INCIDENT ON (B)(6) 2021. AT THIS TIME THE CUSTOMER HAS MADE SEVERAL ATTEMPTS TO GATHER FURTHER INFORMATION ON THE COMPLAINT FROM THE PATIENT WITH NO RESPONSE TO DATE. THE CUSTOMER REPORTED THAT IT IS EVEN QUESTIONABLE AT THIS TIME WHETHER OR NOT THE COMPLAINT WAS RELATED TO THE ORAQUICK HIV TEST OR NOT. THE CUSTOMER WAS NOT PROVIDED WITH DETAILS OF THE PATIENTS CONDITION BUT WAS TOLD EVERYTHING WAS ALRIGHT AT THIS TIME. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE (26MAY2021). THIS EVENT WILL BE CLOSED INTERNALLY IN ORASURE TECHNOLOGIES, INC. COMPLAINT SYSTEM.

    Description of Event or Problem · 0

    ON 16MAR2021 ORASURE TECHNOLOGIES, INC. (OTI) WAS NOTIFIED BY A CUSTOMER THAT A PATIENT INGESTED THE ORAQUICK DEVELOPER SOLUTION FROM THE ORAQUICK ADVANCE INTERNATIONAL HIV-1/2 DEVICE KIT (ITEM#: 1001-0284). THE PATIENT HAD REPORTED TO HAVE AN ALLERGIC REACTION TO THE DEVELOPER SOLUTION AFTER INGESTING. THE ORAQUICK ADVANCE MSDS WAS PROVIDED TO THE CUSTOMER TO FORWARD ON TO THE PATIENT ON (B)(6) 2021 BY OTI SALES. OTI TECHNICAL SERVICES E-MAILED THE CUSTOMER ON (B)(6) 2021 TO INQUIRE FURTHER DETAILS ON THE PATIENTS CONDITION AND THE MEANS IN WHICH THE TESTING WAS BEING ADMINISTERED. THE PACKAGE INSERT FOR THE ORAQUICK ADVANCE RAPID HIV-1/2 DEVICE IS REGISTERED FOR USE BY HEALTHCARE PROFESSIONALS ONLY. AN E-MAIL RECEIVED BY THE CUSTOMER ON 17MAR2021 STATED THAT THE PATIENT WAS IN THE HOSPITAL AND THEY ARE AWAITING FURTHER INFORMATION ON THE INCIDENT. FURTHER INFORMATION IS TO BE PROVIDED AS IT IS COLLECTED FROM THE PATIENT BY THE CUSTOMER. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2021 ORASURE TECHNOLOGIES, INC. (OTI) WAS NOTIFIED BY A CUSTOMER THAT A PATIENT INGESTED THE ORAQUICK DEVELOPER SOLUTION FROM THE ORAQUICK ADVANCE INTERNATIONAL HIV-1/2 DEVICE KIT (ITEM #1001-0284). THE PATIENT HAD REPORTED TO HAVE AN ALLERGIC REACTION TO THE DEVELOPER SOLUTION AFTER INGESTING. THE ORAQUICK ADVANCE MSDS WAS PROVIDED TO THE CUSTOMER TO FORWARD ON TO THE PATIENT ON (B)(6) 2021 BY OTI SALES. OTI TECHNICAL SERVICES E-MAILED THE CUSTOMER ON (B)(6) 2021 TO INQUIRE FURTHER DETAILS ON THE PATIENTS CONDITION AND THE MEANS IN WHICH THE TESTING WAS BEING ADMINISTERED. THE PACKAGE INSERT FOR THE ORAQUICK ADVANCE RAPID HIV-1/2 DEVICE IS REGISTERED FOR USE BY HEALTHCARE PROFESSIONALS ONLY. AN E-MAIL RECEIVED BY THE CUSTOMER ON (B)(6) 2021 STATED THAT THE PATIENT WAS IN THE HOSPITAL AND THEY ARE AWAITING FURTHER INFORMATION ON THE INCIDENT. FURTHER INFORMATION IS TO BE PROVIDED AS IT IS COLLECTED FROM THE PATIENT BY THE CUSTOMER. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416240 ORAQUICK ADVANCE RAPID HIV-1/2 TEST ORAQUICK ADVANCE RAPID HIV-1/2 TEST MTK ORASURE TECHNOLOGIES, INC. 6679094 00608337000887

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization