BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (FRZ MMX)

    MDR report key: 14859624 · Received June 29, 2022

    Report

    Report Number
    0002024674-2022-08677
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    March 16, 2021
    Report Date
    June 29, 2022
    Manufacturer
    DIAGNOSTIC HYBRIDS, INC.
    Product Code
    QJR
    UDI-DI
    30014613339656
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER WAS USING OFF-PI MEDIA AND CLEANING PROCEDURE WITH BLEACH WIPES UNDER THE LID IS NOT RECOMMENDED. A QUIDEL REPRESENTATIVE VISITED THE SITE AND OBSERVED PROCEDURAL ERRORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. ROOT CAUSE: INSUFFICIENT INFO;LAB ENVIRONMENT ISSUE;NO INVESTIGATION REQUIRED;OFF-LABEL USE. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTED ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER COMMUNICATED THE RESULT TESTED NEGATIVE BY MOLECULAR (PCR TESTING). THE CUSTOMER WAS TESTING WITH AN UNAPPROVED VTM (OFF-LABEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154294 SOLANA SARS-COV-2 ASSAY (FRZ MMX) SOLANA SARS-COV-2 ASSAY (FRZ MMX) QJR DIAGNOSTIC HYBRIDS, INC. Coronavirus 188141 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown