BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CEPHEID XPERT XPRESS SARS-COV-2

    MDR report key: 12016173 · Received June 16, 2021

    Report

    Report Number
    MW5101925
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 14, 2021
    Manufacturer
    CEPHEID
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    (B)(6) HOSPITAL IN (B)(6) ADMITTED MY WIFE FOR APPENDICITIS IN THE EMERGENCY ROOM. WHILE BEING ADMITTED THEY TOOK A COVID-19 TEST IN THE ER (CEPHEID XPERT XPRESS SARS-COV-2), THEY ALERTED HER ONCE ADMITTED THAT SHE HAD TESTED POSITIVE FOR COVID-19, HOWEVER SHE WAS NEVER GIVEN A FACT SHEET ABOUT WHICH TEST SHE WAS GIVEN, THEY ALSO USED THIS TEST OUT OF EMERGENCY USE AUTHORIZATION, AS IT IS INTENDED FOR PERSONS SUSPECTED OF HAVING COVID-19 AND SHE WAS IN THE HOSPITAL FOR APPENDICITIS. THE HOSPITAL DENIED RE-TESTING EVEN THOUGH SHE HAD NO SYMPTOMS OF COVID-19 INFECTION. I'D LIKE TO REPORT THIS LAB AND HOSPITAL FOR USING A EUA TEST OUT OF ITS INTENDED PURPOSE AND FOR NOT GIVING HER THE DATA SHEET THAT IS REQUIRED BY EUA. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902783 CEPHEID XPERT XPRESS SARS-COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CEPHEID

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| O