BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 ANTIGEN SELF-TEST

    MDR report key: 13306725 · Received January 19, 2022

    Report

    Report Number
    MW5106798
    Event Type
    Malfunction
    Date Received
    January 19, 2022
    Date of Event
    January 7, 2022
    Report Date
    January 14, 2022
    Manufacturer
    ACCESSS BIO, INCORPORATE
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED THE AT HOME TEST KIT FOR ON/GO COVID TESTING. THE TEST DID NOT REGISTER THE CONTROL LINE WHICH SHOWS THAT THE TEST IS AT LEAST WORKING. MANUFACTURED BY ACCESS BIO, INC. DISTRIBUTED BY (B)(4). I ATTEMPTED TO CALL THE COMPANIES ON (B)(6) 2022 AT 11:05 EST TO COMPLAIN AND ASK FOR A REFUND. BOTH COMPANIES WERE UNREACHABLE. ACCESSBIO SAID THEIR MAILBOX WAS FULL AND THE CALL DISCONNECTED. (B)(4) HAD AN IVR AND I CHOSE TO SPEAK TO CUSTOMER SERVICE, AND THEN IT CONTINUED TO RING WITH NO FURTHER INSTRUCTIONS AND NO ONE ANSWERED THE CALL. THEIR LACK OF CUSTOMER SUPPORT IS UNACCEPTABLE. HOW CAN A COMPANY LAUNCH A PRODUCT AND NOT BE AVAILABLE TO ASK QUESTIONS OR LOG A PRODUCT QUALITY COMPLAINT? ACCESS BIO PHONE NUMBER ON PRODUCT (B)(4). (B)(4) PHONE NUMBER ON PRODUCT (B)(4). LOT NUMBER CP21H12, EXP JAN 2022, (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152374 COVID-19 ANTIGEN SELF-TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACCESSS BIO, INCORPORATE CP21H12

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female