BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOCODE SARS-COV-2 ASSAY KIT

    MDR report key: 11694720 · Received April 20, 2021

    Report

    Report Number
    3007799234-2020-00003
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    October 12, 2020
    Report Date
    November 9, 2020
    Manufacturer
    APPLIED BIOCODE, INC
    Product Code
    QJR
    UDI-DI
    851034007080
    PMA / PMN Number
    EUA200433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    END USER RUN DATA SHOWS THAT THEY HAD A VALID RUN WITH 96 SAMPLES ON (B)(6)2020, 6 OF THE PATIENT SAMPLES WERE POSITIVE FOR A SINGLE TARGET. END USER DATA ALSO SHOWS THAT THE CUSTOMER IS POOLING POSITIVE SAMPLES, USING AN OFF LABEL PROTOCOL THAT THEY HAVE NOT COMPLETED VALIDATION ON. LOW POSITIVE CONTAMINATION APPEARS TO BE OCCURRING NEAR RUNS THAT HAVE POOLED SAMPLES TESTED. END USER NEEDS TO DISINFECT THEIR EXTRACTION AND SETUP AREA TO PREVENT CONTAMINATION. 04/20/2021 CORRECTED REPORT - MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ~6 FALSE POSITIVES THAT WERE NEGATIVE UPON RE-RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589422 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