BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    MDR report key: 17087612 · Received June 8, 2023

    Report

    Report Number
    0002024674-2023-01072
    Event Type
    Malfunction
    Date Received
    June 8, 2023
    Date of Event
    May 9, 2023
    Report Date
    June 8, 2023
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QJR
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: RETAIN TESTING OF M312 #232151 YIELDED EXPECTED RESULTS. UNABLE TO REPLICATE THE CUSTOMER COMPLAINT. PER CUSTOMER'S RESPONSES, SPECIMENS WERE STORED IN AN OFF-LABEL MANNER PRIOR TO PROCESSING. FRESH SAMPLES WERE USED WHEN TESTING WITH ADDITIONAL METHOD WHILE SOLANA TESTING WAS PERFORMED ON 4-DAY OLD FROZEN SPECIMENS. CUSTOMER STATES THAT MOST PROBLEMS OCCURRED WITH MEDICAL EXAMINER SPECIMENS AND THEY WERE NOT AVAILABLE FOR FURTHER ANALYSIS. ROOT CAUSE: CAN NOT DUPLICATE WITH RETAIN TESTING / CUSTOMER SAMPLE STORAGE ERROR SOURCE: EMAIL.

    Description of Event or Problem · 0

    CUSTOMER REPORTING 7 FALSE NEGATIVE SARS RESULTS. CUSTOMER STATES THE SAMPLES ARE MEDICAL EXAMINER SPECIMENS AND WERE NEGATIVE BY SOLANA BUT POSITIVE BY ANOTHER MOLECULAR METHOD. SAMPLES WERE REQUESTED FOR FURTHER EVALUATION BUT NO LONGER AVAILABLE. REPORT 1 OF 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269182 SOLANA SARS-COV-2 ASSAY (LYO MMX) SOLANA SARS-COV-2 ASSAY (LYO MMX) QJR QUIDEL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown