BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    MDR report key: 16690290 · Received April 6, 2023

    Report

    Report Number
    0002024674-2023-00983
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 15, 2023
    Report Date
    April 12, 2023
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QJR
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE M312 SOLANA SARS-COV-2 ASSAY LOT #223435 PERFORMED AS EXPECTED. CUSTOMER RESULTS COULD NOT BE DUPLICATED. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: PHONE.

    Additional Manufacturer Narrative · 0

    UPDATES TO MANUFACTURERS NARRATIVE: INVESTIGATION CONCLUSION: THE M312 SOLANA SARS-COV-2 ASSAY LOT #223435 PERFORMED AS EXPECTED. CUSTOMER RESULTS COULD NOT BE DUPLICATED. CUSTOMER STATES ISSUE IS RESOLVED. CONTAMINATION IS SUSPECT. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: PHONE.

    Description of Event or Problem · 0

    CUSTOMER REPORTING AN UNSPECIFIED NUMBER OF UNCONFIRMED FALSE POSITIVE SARS RESULTS. CUSTOMER STATES A TECHNICIAN HAD ISSUES WITH ALL SAMPLES, INCLUDING CONTROLS RESULTING POSITIVE, BUT IS UNSURE OF NUMBER OF PATIENTS. FOLLOW UP WITH CUSTOMER SHOWS CONTAMINATION IS SUSPECT AND ASSAY IS PERFORMING AS EXPECTED AFTER CONTAMINATION PROCEDURE WAS PERFORMED WITH NEW MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869424 SOLANA SARS-COV-2 ASSAY (LYO MMX) SOLANA SARS-COV-2 ASSAY (LYO MMX) QJR QUIDEL CORPORATION 223435

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown