BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDICAID COVID-19 RAPID ANTIGEN AT HOME TEST

    MDR report key: 16103137 · Received January 4, 2023

    Report

    Report Number
    MW5114163
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    January 3, 2023
    Report Date
    January 3, 2023
    Manufacturer
    PHASE SCIENTIFIC INTERNATIONAL LIMITED
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE VIALS OF BUFFER WERE EMPTY. ALSO THE LOT NUMBER ON THE VIAL WAS WZ04062022A AND THE LOT NUMBER ON THE CARTON WAS 22S0192. ALSO THE EXPIRY ON THE CARTON HAS A TYPO: 2023-05-18 WHILE THE VIAL EXPIRY DATE IS 2023-08-05, MAKING IT CONFUSING WHAT THE EXPIRY DATE IS, MAY OR AUGUST?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122443 INDICAID COVID-19 RAPID ANTIGEN AT HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP PHASE SCIENTIFIC INTERNATIONAL LIMITED 22S0192 WZ04062022A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male