BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (FRZ MMX)

    MDR report key: 14717292 · Received June 16, 2022

    Report

    Report Number
    0002024674-2022-08030
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    March 22, 2021
    Report Date
    June 16, 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: RETAIN TESTING YIELDED EXPECTED RESULTS. NO FALSE POSITIVES WERE OBSERVED IN EITHER THE NEGATIVE CONTROL OR NEGATIVE UTM SAMPLES. ROOT CAUSE:CAN NOT DUPLICATE WITH RETAINS; UNABLE TO DETERMINE. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTED ONE FALSE POSITIVE SARS RESULT. UNKNOWN IF THE RESULT WAS CONFIRMED. CONFIRMATION METHOD(S) NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253849 SOLANA SARS-COV-2 ASSAY (FRZ MMX) SOLANA SARS-COV-2 ASSAY (FRZ MMX) QJR DIAGNOSTIC HYBRIDS, INC. Coronavirus 110420 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown