BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    MDR report key: 16595503 · Received March 22, 2023

    Report

    Report Number
    0002024674-2023-00782
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    February 23, 2023
    Report Date
    March 22, 2023
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QJR
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: QUIDELORTHO PERSONNEL WAS SENT ONSITE FOR FURTHER TROUBLESHOOTING AND TRAINING WHICH FOUND THE ISSUE MOST LIKELY CAUSED BY CONTAMINATION (CONTAMINATED NEGATIVE KIT CONTROL) AND CARRY OVER. THE M312 SOLANA SARS-COV-2 ASSAY LOT #228726 PERFORMED AS EXPECTED. CUSTOMER RESULTS COULD NOT BE DUPLICATED. ISSUE RESOLVED WITH TECHNICAL SUPPORT AND FAS ON-SITE VISIT. ROOT CAUSE: CAN NOT DUPLICATE WITH RETAIN TESTING. CUSTOMER ISSUE MOST LIKELY DUE TO CONTAMINATION. SOURCE: PHONE.

    Description of Event or Problem · 0

    CUSTOMER REPORTING 3 POSSIBLE FALSE POSITIVE SARS RESULTS. CUSTOMER IS ALSO EXPERIENCING ISSUES WITH NEGATIVE KIT CONTROL AND OTHER NEGATIVE CONTROL PANELS RUNNING POSITIVE. CARRY OVER AND/OR CONTAMINATION IS SUSPECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14002 SOLANA SARS-COV-2 ASSAY (LYO MMX) SOLANA SARS-COV-2 ASSAY (LYO MMX) QJR QUIDEL CORPORATION 228726

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown