BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (FRZ MMX)

    MDR report key: 14621445 · Received June 7, 2022

    Report

    Report Number
    0002024674-2022-06116
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    September 17, 2021
    Report Date
    June 7, 2022
    Manufacturer
    DIAGNOSTIC HYBRIDS, INC.
    Product Code
    QJR
    UDI-DI
    30014613339656
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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. SUSPECTED CONTAMINATION AS BLANKS AND KNOWN NEGATIVE PATIENT SAMPLES WERE RESULTING POSITIVE. AFTER THE DECONTAMINATION PROCEDURE, QC AND KNOWN NEGATIVE PATIENTS RESULTED AS EXPECTED. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTED ONE FALSE POSITIVE RESULT. UNKNOWN IF THE RESULT WAS CONFIRMED. CONFIRMATION METHOD(S) NOT PROVIDED. CUSTOMER ALSO REPORTED AN ADDITIONAL 24 FALSE POSITIVE RESULTS, WHICH ARE CAPTURED IN SEPARATE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577787 SOLANA SARS-COV-2 ASSAY (FRZ MMX) SOLANA SARS-COV-2 ASSAY (FRZ MMX) QJR DIAGNOSTIC HYBRIDS, INC. Coronavirus 200323 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown