BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    MDR report key: 16676336 · Received April 4, 2023

    Report

    Report Number
    0002024674-2023-00844
    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 7 OF 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130429 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