BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL LYRA DIRECT SARS-COV-2 ASSAY (M124)

    MDR report key: 11698401 · Received April 20, 2021

    Report

    Report Number
    1000122536-2021-00015
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    February 12, 2021
    Report Date
    April 20, 2021
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QJR
    UDI-DI
    30014613339144
    PMA / PMN Number
    EUA200423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONAL SUMMARY: REVIEW OF AMPLIFICATION CURVE SCREENSHOTS PROVIDED BY CUSTOMER SHOW MULTIPLE CURVES CROSSING TWO THRESHOLDS. UNABLE TO DECIPHER WHAT EACH CURVE REPRESENTS. REVIEW OF QC DOCUMENTS SHOW THAT M124 LOT #190790 PERFORMED AS EXPECTED. CUSTOMER TROUBLESHOOTING SHOWED THAT THEIR PROCESS BUFFER BECAME CONTAMINATED AND WAS THE SOURCE OF THE FALSE POSITIVES. NO FURTHER INVESTIGATION NECESSARY.

    Description of Event or Problem · 1

    FALSE POSITIVE: CUSTOMER RECEIVING ALL POSITIVE RESULTS WHEN RUNNING LYRA DIRECT SARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590779 QUIDEL LYRA DIRECT SARS-COV-2 ASSAY (M124) LYRA DIRECT SARS-COV-2 ASSAY QJR QUIDEL CORPORATION Coronavirus 190709 30014613339144

    Patients

    Seq Age Sex Outcome Treatment
    1