BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    MDR report key: 16676734 · Received April 4, 2023

    Report

    Report Number
    0002024674-2023-00977
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 11, 2023
    Report Date
    April 4, 2023
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QJR
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE M312 SOLANA SARS-COV-2 ASSAY LOT #220875 PERFORMED AS EXPECTED. CUSTOMER RESULTS COULD NOT BE DUPLICATED. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: PHONE.

    Description of Event or Problem · 0

    CUSTOMER REPORTING ALL PATIENTS SHOWING POSITIVE SARS RESULTS INCLUDING NEGATIVE CONTROL (20 PATIENT RESULTS TOTAL). CUSTOMER STATES THE RESULTS WERE NEGATIVE BY AN OTC RAPID ANTIGEN TEST. REPORT 15 OF 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129523 SOLANA SARS-COV-2 ASSAY (LYO MMX) SOLANA SARS-COV-2 ASSAY (LYO MMX) QJR QUIDEL CORPORATION 220875

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown