BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (FRZ MMX)

    MDR report key: 14605743 · Received June 6, 2022

    Report

    Report Number
    0002024674-2022-06636
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    October 15, 2021
    Report Date
    June 3, 2022
    Manufacturer
    DIAGNOSTIC HYBRIDS, INC.
    Product Code
    QJR
    UDI-DI
    30014613339656
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: REVIEW OF CUSTOMER DATA SHOWS THAT THE PATIENT SAMPLES IN QUESTION PRODUCE ROBUST SARS AND PRC AMPLIFICATION CURVES. NO POSITIVE OR NEGATIVE CONTROLS WERE INCLUDED IN THESE RUNS. RETAIN TESTING OF LOT #203040 SHOWS THAT PRODUCT PERFORMS AS EXPECTED AND NO FALSE POSITIVES WERE OBSERVED. UNABLE TO DUPLICATE CUSTOMER COMPLAINT OR DETERMINE ROOT CAUSE. ROOT CAUSE: CANNOT DUPLICATE WITH RETAINS;UNABLE TO DETERMINE. SOURCE: PHONE.

    Description of Event or Problem · 0

    REPORTED ONE FALSE POSITIVE RESULT FOR AN ASYMPTOMATIC PATIENT THE CUSTOMER COMMUNICATED THE RESULT TESTED NEGATIVE BY MOLECULAR (PCR TESTING). THE CONFIRMATORY TESTING SAMPLE WAS COLLECTED TWO DAYS AFTER THE ORIGINAL SAMPLE WAS COLLECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184687 SOLANA SARS-COV-2 ASSAY (FRZ MMX) SOLANA SARS-COV-2 ASSAY (FRZ MMX) QJR DIAGNOSTIC HYBRIDS, INC. Coronavirus 203040 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown