BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOCODE SARS-COV-2 ASSAY KIT

    MDR report key: 11695075 · Received April 20, 2021

    Report

    Report Number
    3007799234-2021-00003
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 26, 2021
    Report Date
    April 19, 2021
    Manufacturer
    APPLIED BIOCODE, INC
    Product Code
    QJR
    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

    THE DEVICE AND/OR SUSPECT SAMPLE WAS NOT RETURNED FOR EVALUATION. THE SARS-COV-2 REGENT LOT NOT SPECIFIED BY THE CUSTOMER. THE CUSTOMER STATED THAT THEY BELIEVE THAT THIS WAS A LOW POSITIVE SAMPLE THAT DEGRADED WITH ADDITIONAL FREEZE/THAW CYCLE WHEN SENDING THE SAMPLE TO THE MARYLAND DEPARTMENT OF HEALTH. THIS ISSUE IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION, BASED ON THE CONDITIONS OF AUTHORIZATION. 04/20/2021 - CORRECTED MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    PER REQUESTS FROM (B)(6), THE CUSTOMER SUBMITTED A NUMBER OF POSITIVE SAMPLES TO STATE LAB, THE CUSTOMER RECEIVED TOTAL 12 REPORTS FROM STATE OF (B)(6) DEPARTMENT OF HEALTH LAB ADMINISTRATION, 11 ARE POSITIVE AND 1 NEGATIVE. THE SOLE NEGATIVE IS LIKELY DUE TO VIRUS RNA DEGRADATION DURING FREEZE AND THAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589035 BIOCODE SARS-COV-2 ASSAY KIT SARS-COV-2 ASSAY QJR APPLIED BIOCODE, INC COV-2.1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1