BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOCODE SARS-COV-2 ASSAY KIT

    MDR report key: 11694884 · Received April 20, 2021

    Report

    Report Number
    3007799234-2021-00002
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 5, 2021
    Manufacturer
    APPLIED BIOCODE, INC
    Product Code
    QJR
    UDI-DI
    851034007080
    PMA / PMN Number
    EUA200433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF DATA PROVIDED BY THE CUSTOMER, ALL OF THE DISCREPANT RESULTS ARE NEAR THE LIMIT OF DETECTION OF OUR ASSAY AND LIKELY BELOW THE LIMIT OF DETECTION OF THE LUMINEX ARIES ASSAY SYSTEM. THIS REPORT IS MADE OUT OF AN ABUNDANCE OF CAUTION BASED ON THE CONDITIONS OF AUTHORIZATION FOR THE EUA. 04/20/2021 - CORRECT MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 5 SAMPLES THAT WERE DETECTED BY BIOCODE SARS-COV-2 ASSAY (SINGLE TARGET POSITIVE). FOUR WERE RETESTED ON THE LUMINEX AIRES SYSTEM AS NEGATIVE. ONE WAS RETESTED ON THE HOLOGIC PANTHER SYSTEM AS NEGATIVE. SAMPLES ARE NASAL, COLLECTED IN SALINE. STORED ROOM TEMPERATURE AFTER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589497 BIOCODE SARS-COV-2 ASSAY KIT SARS-COV-2 ASSAY QJR APPLIED BIOCODE, INC COV-2.1 AK-07002 851034007080

    Patients

    Seq Age Sex Outcome Treatment
    1