BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    MDR report key: 20260665 · Received September 19, 2024

    Report

    Report Number
    0002024674-2024-00452
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 30, 2024
    Report Date
    September 18, 2024
    Manufacturer
    DIAGNOSTIC HYBRIDS, INC. DBA ORTHO-CLINICAL DIAGNO
    Product Code
    QJR
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES WERE RETURNED OUTSIDE THE TIME AND STORGE LIMITATIONS, RETURNS WERE NOT TESTED.. NO INVESTIGATION REQUIRED. COMPLAINT SOURCE: EMAIL.

    Description of Event or Problem · 0

    REPORTED ONE FALSE NEGATIVE RESULT. THE CUSTOMER COMMUNICATED THE RESULT WAS POSITIVE BY ANOTHER MOLECULAR METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487472 SOLANA SARS-COV-2 ASSAY (LYO MMX) SOLANA SARS-COV-2 ASSAY (LYO MMX) QJR DIAGNOSTIC HYBRIDS, INC. DBA ORTHO-CLINICAL DIAGNO 251144

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown