BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    MDR report key: 11416259 · Received March 4, 2021

    Report

    Report Number
    3012642695-2021-00137
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 5, 2021
    Report Date
    March 4, 2021
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QKP
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL: 3012642695-02/19/21-002-C. THIS IS REPORT 21 OF 32 FOR THIS FACILITY AND AWARE DATE. THE CUSTOMER REPORTED A SUSPECTED FALSE (INCORRECT) POSITIVE RESULT FROM A RAPID RESULT COVID TEST SYSTEM ON AN INDIVIDUAL SYMPTOMATIC PATIENT. NO SECONDARY/CONFIRMATORY TESTING WAS REPORTED. LOT 5000305 HAS BEEN PLACED INTO QUARANTINE DUE TO OBSERVATIONS OF A HIGHER POTENTIAL FOR FALSE POSITIVE RESULTS. A ROOT CAUSE ANALYSIS AND CORRECTIVE/PREVENTIVE ACTION PLAN ARE PENDING COMPLETION.

    Description of Event or Problem · 1

    THIS IS REPORT 21 OF 32 FOR THIS FACILITY AND AWARE DATE. THE CUSTOMER REPORTED A SUSPECTED FALSE (INCORRECT) POSITIVE RESULT FROM A RAPID RESULT COVID TEST SYSTEM ON AN INDIVIDUAL SYMPTOMATIC PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312230 LUMIRADX SARS-COV-2 AG TEST STRIP KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP LUMIRADX UK LTD. 5000305

    Patients

    Seq Age Sex Outcome Treatment
    1