BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (FRZ MMX)

    MDR report key: 14717998 · Received June 16, 2022

    Report

    Report Number
    0002024674-2022-08041
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    April 12, 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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: REVIEW OF CUSTOMER DATA SHOWS POSITIVE SARS AMPLIFICATION CURVES IN ALL SAMPLE WELLS. PRC AMPLIFICATION CURVES LOOK NORMAL. RETAIN TESTING, HOWEVER, YIELDED EXPECTED RESULTS. NO FALSE POSITIVES WERE OBSERVED IN THE NEGATIVE CONTROL. UNABLE TO DUPLICATE CUSTOMER COMPLAINT. ROOT CAUSE:CAN NOT DUPLICATE WITH RETAINS;UNABLE TO DETERMINE SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTED ONE FALSE POSITIVE SARS RESULT. THE CUSTOMER COMMUNICATED THE RESULT TESTED NEGATIVE BY MOLECULAR (PCR TESTING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1857216 SOLANA SARS-COV-2 ASSAY (FRZ MMX) SOLANA SARS-COV-2 ASSAY (FRZ MMX) QJR DIAGNOSTIC HYBRIDS, INC. Coronavirus 111320 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown