BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    MDR report key: 17358515 · Received July 20, 2023

    Report

    Report Number
    0002024674-2023-01409
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 22, 2023
    Report Date
    August 11, 2023
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QJR
    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

    INVESTIGATION CONCLUSION: TO BE DETERMINED. ROOT CAUSE: TO BE DETERMINED. SOURCE: PHONE.

    Additional Manufacturer Narrative · 0

    UPDATES TO MANUFACTURERS NARRATIVE INVESTIGATION CONCLUSION: FAS AND CUSTOMER PREPARED MULTIPLE RUNS ALL YIELDING EXPECTED RESULTS. CUSTOMER TO ORDER BETTER FITTING PIPETTE TIPS, ILL-FITTING TIPS MAY BE CAUSE OF FP. CUSTOMER STATES ASSAY IS WORKING AS EXPECTED. ROOT CAUSE: UNABLE TO FULLY DETERMINE ; POSSIBLE ISSUE WITH CUSTOMER EQUIPMENT SOURCE: PHONE.

    Description of Event or Problem · 0

    CUSTOMER REPORTING 4 POTENTIAL FALSE POSITIVE SARS RESULTS WHEN COMPARING THE SAME METHOD USING A DIFFERENT INSTRUMENT ON EMPLOYEE SCREEN SAMPLES. CONTAMINATION IS SUSPECT AS QUIDELORTHO PERSONNEL ONSITE VISIT FOUND INCORRECT/ILL-FITTING PIPETTE TIPS WERE USED TO TRANSFER PATIENT SAMPLES TO WELLS. INVESTIGATION IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839563 SOLANA SARS-COV-2 ASSAY (LYO MMX) SOLANA SARS-COV-2 ASSAY (LYO MMX) QJR QUIDEL CORPORATION 233004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown