BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOCODE SARS-COV-2 ASSAY KIT

    MDR report key: 11694799 · Received April 20, 2021

    Report

    Report Number
    3007799234-2021-00001
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 30, 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 COULD BE SAMPLES NEAR THE LIMIT OF DETECTION FOR OUR ASSAY, OR THEY COULD BE SARS-COV-2 AMPLICON CONTAMINATION. 04/20/2021 - UPDATED REPORT WITH CORRECT MANUFACTURER REPORT NUMBER

    Description of Event or Problem · 1

    CUSTOMER REPORTED A HIGHER THAN ANTICIPATED POSITIVITY RATE FOR SARS-COV-2 RESULTS. APPROXIMATELY (B)(6) SPECIMENS TESTED HAD SARS-COV-2 DETECTED, WHICH IS DOUBLE THE HISTORICAL DETECTION RATE OF SARS-COV-2 SINCE THEY WENT LIVE WITH THE SARS-COV-2 TESTING IN (B)(6) 2020. THE USER REPEATED THE WHOLE RUN AND THE 10 SINGLE TARGET POSITIVES ON THE ORIGINAL RUN, ONLY 1 CAME UP POSITIVE IN THE REPEAT RUN. THE ONE SAMPLE THAT CAME UP POSITIVE ON REPEAT WAS DUAL POSITIVE ON THE REPEAT RUN (SAMPLE (B)(4)). FROM THE ORIGINAL RUN THE 5 DUAL POSITIVES, 4 REPEATED AS DUAL POSITIVE AND 1 REPEATED NOT DETECTED. IN THE REPEAT RUN THERE WERE 4 SAMPLES THAT CAME UP AS SINGLE TARGET POSITIVE THAT WERE NOT DETECTED IN THE ORIGINAL RUN. SAMPLES ARE HELD AT ROOM TEMPERATURE BETWEEN TESTING EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589460 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