BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (FRZ MMX)

    MDR report key: 14578897 · Received June 2, 2022

    Report

    Report Number
    0002024674-2022-05642
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    December 10, 2021
    Report Date
    May 27, 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: INSUFFICIENT INFORMATION. ROOT CAUSE: INSUFFICIENT INFORMATION. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTED ONE FALSE POSITIVE SARS RESULT FOR ONE PATIENT. THE CUSTOMER COMMUNICATED THE RESULT WAS CONFIRMED NEGATIVE BY MOLECULAR (PCR TESTING). THE CUSTOMER HAS COMMUNICATED THREE ADDITIONAL PATIENT EVENTS THAT ARE CAPTURED IN SEPARATE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198047 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