BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (FRZ MMX)

    MDR report key: 14684921 · Received June 14, 2022

    Report

    Report Number
    0002024674-2022-06641
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    September 3, 2021
    Report Date
    June 14, 2022
    Manufacturer
    DIAGNOSTIC HYBRIDS, INC.
    Product Code
    QJR
    UDI-DI
    30014613339656
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ANALYZER DATA WAS OBTAINED AND ANALYZED AS PART OF THE INVESTIGATION. ANALYSIS DID NOT CONCLUDE A PRODUCT PERFORMANCE ISSUE. RETAINED MATERIAL SHOWED NO ISSUE WITH PRODUCT PERFORMANCE. A QUIDEL REPRESENTATIVE VISITED THE SITE AND OBSERVED PROCEDURAL ERRORS AND USE OF AN OFF-LABEL VIRAL TRANSPORT MEDIA (VTM) THAT MAY HAVE CONTRIBUTED TO THE EVENT. ROOT CAUSE: CUSTOMER PROCEDURAL ERROR;UNABLE TO DETERMINE. SOURCE: EMAIL.

    Description of Event or Problem · 0

    REPORTED ONE FALSE NEGATIVE SARS RESULT. THE CUSTOMER COMMUNICATED THE RESULT TESTED POSITIVE BY MOLECULAR (PCR TESTING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990976 SOLANA SARS-COV-2 ASSAY (FRZ MMX) SOLANA SARS-COV-2 ASSAY (FRZ MMX) QJR DIAGNOSTIC HYBRIDS, INC. Coronavirus 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown