BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTART COVID-19 ANTIGEN (RHCM-02071)

    MDR report key: 13499521 · Received February 8, 2022

    Report

    Report Number
    MW5107299
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Date of Event
    January 31, 2022
    Report Date
    February 6, 2022
    Manufacturer
    ACCESS BIO INCORPORATE
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USED COVID, RAPID, AT HOME, ANTIGEN TEST. BRAND CARESTART COVID-19 ANTIGEN (RCHM-02071) MANUFACTURED BY ACCESS BIO, INC., FOR INTRIVO DIAGNOSTICS, INC. (LOT CH21A24, INITIAL EXPIRATION DATE OF JUN 2021, EXTENDED BY FDA TO 12 MONTHS FROM ORIGINAL DATE). POSITIVE AND NEGATIVE CONTROL PASSED ON (B)(6) 2022. WEAK POSITIVE FOR HUMAN TEST (B)(6) 2022 0900 EST. NEGATIVE CLINIC ADMINISTERED, PCR TEST COLLECTED AT 1130 EST. ANOTHER WEAK POSITIVE ANTIGEN TEST ON (B)(6) 2022. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90970 CARESTART COVID-19 ANTIGEN (RHCM-02071) CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACCESS BIO INCORPORATE CH21A24
    90971 CARESTART COVID-19 ANTIGEN (RHCM-02071) CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACCESS BIO INCORPORATE CH21A24

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female