BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 AT-HOME TEST

    MDR report key: 16061598 · Received December 28, 2022

    Report

    Report Number
    1823260-2022-04213
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    December 7, 2022
    Report Date
    December 28, 2022
    Manufacturer
    SD BIOSENSOR, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210661
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONSUMER WAS A SUBJECT OF A STUDY. THE CASE WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. THERE IS A LOW PROBABILITY OF FALSE POSITIVES OCCURRING. POTENTIAL CAUSES OF SAMPLE DEVIATION AND POOR REPRODUCIBILITY CAN BE DUE TO MUCOUS MEMBRANES PRESENT IN THE NOSE, MUCIN AND IGA ACT AS A BRIDGE BETWEEN CAPTURE AND DETECTOR, WHICH MAY CAUSE NON-SPECIFICITY. THE TEST DOES NOT DIFFERENTIATE BETWEEN SARS-COV AND SARS-COV-2. REFER TO THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE. IN GENERAL, THE RAPID AG TEST RESULT SHOULD NOT BE THE SOLE BASIS FOR THE DIAGNOSIS; DEPENDING ON THE SITUATION CONFIRMATORY TESTING IS REQUIRED (PCR).

    Description of Event or Problem · 0

    THE PHYSICIAN REPORTED A FALSE POSITIVE RESULT WITH THE COVID-19 AT-HOME TEST COMPARED TO A NEGATIVE PCR TEST. ON (B)(6) 2022, THE CONSUMER HAD A COVID-19 AT-HOME TEST AND THE RESULT WAS POSITIVE. ON (B)(6) 2022, THE CONSUMER HAD A NASAL PCR TEST AND THE RESULT WAS NEGATIVE. THE TESTS WERE PERFORMED WITHIN 24 HOURS. THE CONSUMER HAS NO SYMPTOMS AND SELF-ISOLATED FOR 5 DAYS AS PER CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) GUIDELINES AS A PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105969 COVID-19 AT-HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP SD BIOSENSOR, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown