BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11698416 · Received April 20, 2021

    Report

    Report Number
    1000122536-2021-00010
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    February 9, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATIONAL SUMMARY: REVIEW OF CUSTOMER DATA SHOWS THAT SAMPLE HI-02 YIELDED AN ATYPICAL CURVE IN ONE RUN WHICH GENERATED A POSITIVE RESULT DUE TO THE CURVE CROSSING THE SARS-COV-2 THRESHOLD. A SECOND RUN OF THE SAME SAMPLE SHOWS A FLAT CURVE IN THE SARS-COV-2 CHANNEL. GIVEN THE ATYPICAL AMPLIFICATION BEHAVIOR OF THE CURVE IN THE FIRST RUN, IT IS POSSIBLE THAT THERE COULD BE SOME INTERFERENCE COMING FROM THE SAMPLE. RETAIN TESTING NOT PERFORMED SINCE LOT # NOT PROVIDED BY CUSTOMER. WHILE QC WAS UNABLE TO DETERMINE THE ROOT CAUSE, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 0

    FALSE POSITIVE: CUSTOMER REPORTED POTENTIAL FALSE POSITIVE RESULT ON LYRA DIRECT SARS-COV-2.

    Additional Manufacturer Narrative · 1

    INVESTIGATIONAL SUMMARY: REVIEW OF CUSTOMER DATA SHOWS THAT SAMPLE HI-02 YIELDED AN ATYPICAL CURVE IN ONE RUN WHICH GENERATED A POSITIVE RESULT DUE TO THE CURVE CROSSING THE SARS-COV-2 THRESHOLD. A SECOND RUN OF THE SAME SAMPLE SHOWS A FLAT CURVE IN THE SARS-COV-2 CHANNEL. GIVEN THE ATYPICAL AMPLIFICATION BEHAVIOR OF THE CURVE IN THE FIRST RUN, IT IS POSSIBLE THAT THERE COULD BE SOME INTERFERENCE COMING FROM THE SAMPLE. RETAIN TESTING NOT PERFORMED SINCE LOT # NOT PROVIDED BY CUSTOMER. WHILE QC WAS UNABLE TO DETERMINE THE ROOT CAUSE, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    FALSE NEGATIVE: CUSTOMER REPORTED POTENTIAL FALSE POSITIVE RESULT ON LYRA DIRECT SARS-COV-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589607 QUIDEL LYRA DIRECT SARS-COV-2 ASSAY (M124) LYRA DIRECT SARS-COV-2 ASSAY QJR QUIDEL CORPORATION CORONAVIRUS 30014613339144

    Patients

    Seq Age Sex Outcome Treatment
    1