BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (FRZ MMX)

    MDR report key: 14806709 · Received June 24, 2022

    Report

    Report Number
    0002024674-2022-08644
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    May 3, 2021
    Report Date
    June 24, 2022
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QJR
    UDI-DI
    30014613339656
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: A REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY ADVERSE TRENDS. ROOT CAUSE: INSUFFICIENT INFORMATION. SOURCE: EMAIL.

    Description of Event or Problem · 0

    REPORTED FALSE NEGATIVE RESULT FOR 1 PATIENT. IT IS UNKNOWN IF THE PATIENT WAS SYMPTOMATIC. THE CUSTOMER COMMUNICATED THE RESULT WAS POSITIVE BY ANOTHER MOLECULAR METHOD WHICH RESULTED IN HIGH CT VALUES AND SUSPECTED LOW LOD. THE CUSTOMER ALSO STATED THE SAMPLES WERE STORED FROZEN FOR MORE THAN 4 DAYS PRIOR TO TESTING WITH SOLANA (OFF-LABEL USE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267981 SOLANA SARS-COV-2 ASSAY (FRZ MMX) SOLANA SARS-COV-2 ASSAY (FRZ MMX) QJR QUIDEL CORPORATION Coronavirus 188739 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown