BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    MDR report key: 11416134 · Received March 4, 2021

    Report

    Report Number
    3012642695-2021-00126
    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

    CORRECTION #: 3012642695-02/19/21-002-C. THIS IS REPORT 10 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. CONFIRMATORY TESTING OF THE PATIENT VIA POLYMERASE CHAIN REACTION (PCR) TESTING WAS NEGATIVE. 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 10 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
    313369 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