BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    MDR report key: 16064703 · Received December 28, 2022

    Report

    Report Number
    0002024674-2022-10545
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    November 30, 2022
    Report Date
    March 16, 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

    UPDATES MADE. UPDATES TO MANUFACTURERS NARRATIVE: INVESTIGATION CONCLUSION: REVIEW OF CUSTOMER DATA USING KNOWN CONTROL SAMPLES SHOWED INCONSISTENCIES FROM REACTION TO REACTION LEADING TO THE CONCLUSION THAT THE ISSUE IS RELATED TO TECHNICIAN TECHNIQUE. QUIDELORTHO PERSONEL WAS SENT ONSITE FOR FURTHER TROUBLESHOOTING AND TRAINING. ISSUE IS NO LONGER PRESENT SINCE ONSITE VISIT. ROOT CAUSE: UNABLE TO FULLY DETERMINE ; MOST LIKELY TECHNICIAN TECHNIQUE AND USE OF LABORATORY EQUIPMENT. SOURCE: PHONE.

    Additional Manufacturer Narrative · 0

    CUSTOMER SENT PATIENT SAMPLE IN FOR TESTING AND QUIDELORTHO TESTING RESULTS WERE ALL POSITIVE FOR SARS IN BOTH SOLANA AND LYRA (PCR) PLATFORMS, MATCHING THE CONFIRMATION TESTING RESULTS. CUSTOMER'S FALSE NEGATIVE RESULTS DUE TO PROCEDURAL ISSUES SOLVED BY FURTHER TRAINING.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    CUSTOMER REPORTING FALSE NEGATIVE SARS RESULT. CUSTOMER STATES THE RESULT WAS CONFIRMED POSITIVE WHEN THE RESULT WAS REPEATED ON THE SAME ASSAY AND BY AN ANTIGEN TEST. IT IS NOTED THAT THE CUSTOMER IS EXPERIENCING POSITIVE CONTROL FAILURES AS WELL DURING THEIR RUNS WITH THE POSITIVE CONTROL RESULTING NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466307 SOLANA SARS-COV-2 ASSAY (LYO MMX) SOLANA SARS-COV-2 ASSAY (LYO MMX) QJR QUIDEL CORPORATION 221699

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown