BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    MDR report key: 20561396 · Received October 29, 2024

    Report

    Report Number
    0002024674-2024-00685
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 29, 2024
    Manufacturer
    DIAGNOSTIC HYBRIDS, INC. DBA ORTHO-CLINICAL DIAGNO
    Product Code
    QJR
    UDI-DI
    30014613339427
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED FALSE POSITIVES. TSS WORKED WITH CUSTOMER AND CAME TO THE CONCLUSION THAT THE FALSE POSITIVES WERE DUE TO ENVIRONMENTAL/CARRY-OVER CONTAMINATION. CUSTOMER FIXED PROBLEM AND HAS REPORTED NO FURTHER ISSUES. NO FURTHER INVESTIGATION IS REQUIRED. SOURCE OF COMPLAINT WAS A PHONE CALL.

    Description of Event or Problem · 0

    CUSTOMER REPORTED 5 FALSE POSITIVE PATIENT RESULTS. NO CONFIRMATORY TESTING WAS PERFORMED. ISSUE RESOLVED BY DECONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339679 SOLANA SARS-COV-2 ASSAY (LYO MMX) SOLANA SARS-COV-2 ASSAY (LYO MMX) QJR DIAGNOSTIC HYBRIDS, INC. DBA ORTHO-CLINICAL DIAGNO 253511 30014613339427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown