BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLANA SARS-COV-2 ASSAY (LYO MMX)

    MDR report key: 17637460 · Received August 28, 2023

    Report

    Report Number
    0002024674-2023-01596
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    July 31, 2023
    Report Date
    August 28, 2023
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QJR
    PMA / PMN Number
    EUA203087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: USE OF EXPIRED PRODUCT IS SUSPECT ROOT CAUSE: ISSUE LIKELY DUE TO THE USAGE OF EXPIRED KITS SOURCE: PHONE.

    Description of Event or Problem · 0

    CUSTOMER REPORTING 10 FALSE NEGATIVE SARS RESULTS. CUSTOMER STATES THE RESULTS WERE CONFIRMED POSITIVE BY PCR METHOD. NUMEROUS ATTEMPTS WERE MADE TO GATHER FURTHER INFORMATION AND TROUBLESHOOT WITH THE CUSTOMER BY MULTIPLE QUIDELORTHO EMPLOYEES WITHOUT SUCCESS. BASED ON PREVIOUS ORDER HISTORY IT IS PRESUMED THE PRODUCT THEY USED TO PRODUCE THE 10 RESULTS WAS EXPIRED. REPORT 9 OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434801 SOLANA SARS-COV-2 ASSAY (LYO MMX) SOLANA SARS-COV-2 ASSAY (LYO MMX) QJR QUIDEL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown