BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (FRZ MMX)

    MDR report key: 14690459 · Received June 14, 2022

    Report

    Report Number
    0002024674-2022-06637
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    September 10, 2021
    Report Date
    June 14, 2022
    Manufacturer
    DIAGNOSTIC HYBRIDS, INC.
    Product Code
    QJR
    UDI-DI
    30014613339656
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ANALYZER DATA WAS OBTAINED AND ANALYZED AS PART OF THE INVESTIGATION. ANALYSIS DID NOT CONCLUDE A PRODUCT PERFORMANCE ISSUE. A PATIENT SAMPLE WAS SUBMITTED FOR TESTING. THE SAMPLE WAS NEAR THE LOD ON THE QUIDEL PCR PLATFORM. ROOT CAUSE: UNABLE TO DETERMINE. SOURCE: EMAIL.

    Description of Event or Problem · 0

    REPORTED ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER COMMUNICATED THE RESULT TESTED NEGATIVE BY MOLECULAR (PCR TESTING). WHEN THE SAME SAMPLE WAS TESTED THE NEXT DAY, THE SAMPLE WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659258 SOLANA SARS-COV-2 ASSAY (FRZ MMX) SOLANA SARS-COV-2 ASSAY (FRZ MMX) QJR DIAGNOSTIC HYBRIDS, INC. Coronavirus 202253 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown