BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (FRZ MMX)

    MDR report key: 14690519 · Received June 14, 2022

    Report

    Report Number
    0002024674-2022-06649
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    January 28, 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
    MA, 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. DATA REVIEW SHOWS THAT THERE IS A STRONG LIKELIHOOD THAT THE CUSTOMER HAS A CONTAMINATION ISSUE. TECHNICAL SUPPORT ALSO NOTED THAT TECHNICIANS AT THE SITE HAVE REMOVED REACTION TUBES THAT HAD LIQUID ON THE OUTSIDE. REASON FOR LEAK UNKNOWN BUT THIS IS LIKELY WHAT HAS CAUSED THEIR CONTAMINATION. ROOT CAUSE: LEAKING PRODUCT; 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
    2813437 SOLANA SARS-COV-2 ASSAY (FRZ MMX) SOLANA SARS-COV-2 ASSAY (FRZ MMX) QJR DIAGNOSTIC HYBRIDS, INC. Coronavirus 188371 30014613339656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown