BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    MDR report key: 19033740 · Received April 3, 2024

    Report

    Report Number
    0002024674-2024-00214
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 5, 2024
    Report Date
    April 3, 2024
    Manufacturer
    QUIDELORTHO CORPORATION
    Product Code
    QJR
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: QUIDELORTHO PERSONNEL VISITED CUSTOMER SITE AND OBSERVED/PERFORMED TESTING USING TRAINING PANEL AND CONTROLS. FOUR TECHNICIANS PERFORMED TESTING, ALL RUNS RESULTED AS EXPECTED. QUIDELORTHO PERSONNEL NOTED SEVERAL OFF PRODUCT INSERT PRACTICES UPON OBSERVATION. PROVIDED CUSTOMER WITH RETRAINING. ROOT CAUSE: CUSTOMER PROCEDURAL ERROR;IMPROPER SPECIMEN TRANSPORT SOURCE: PHONE,

    Description of Event or Problem · 0

    CUSTOMER REPORTING AN UNKNOWN NUMBER OF POTENTIAL FALSE POSITIVE SARS RESULTS. THROUGH AN ONSITE VISIT BY QUIDELORTHO PERSONNEL IT WAS FOUND THAT KIT CONTROL FAILURES OCCURRED ON SEVERAL OF THE ASSAYS, AS WELL AS MULTIPLE IMPROPER PROCEDURAL STEPS/DEVIATIONS FROM PRODUCT INSERT GUIDELINES. CUSTOMER REPORTS BETTER ASSAY PERFORMANCE SINCE RETRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783331 SOLANA SARS-COV-2 ASSAY (LYO MMX) SOLANA SARS-COV-2 ASSAY (LYO MMX) QJR QUIDELORTHO CORPORATION 235100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown