BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    MDR report key: 11381972 · Received February 25, 2021

    Report

    Report Number
    3012642695-2021-00051
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    January 25, 2021
    Report Date
    February 25, 2021
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QKP
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL NUMBER: 3012642695-02/17/21-001-C. THIS IS REPORT 4 OF 10 FOR THIS FACILITY AND AWARE DATE. THE CUSTOMER REPORTED A SUSPECTED FALSE (INCORRECT) POSITIVE RESULT ON A RAPID RESULT COVID TEST SYSTEM ON A PATIENT. NO FURTHER PATIENT DATA WAS AVAILABLE. CONFIRMATORY TESTING OF THE PATIENT HAS NOT BEEN PROVIDED. A FIELD CORRECTIVE ACTION IN THE FORM OF AN INSTRUMENT SOFTWARE UPDATE WAS ISSUED TO ADDRESS LOT 5000229 DUE TO OBSERVATIONS OF A HIGHER POTENTIAL FOR FALSE POSITIVE RESULTS. A ROOT CAUSE ANALYSIS AND CORRECTIVE/PREVENTIVE ACTION PLAN SUMMARY WAS PERFORMED AND IMPLEMENTED UNDER DOCUMENT NUMBER (B)(4), EFFECTIVE DATE 17 FEBRUARY 2021 AND WAS SUBMITTED TO SUPPORT THE FIELD CORRECTIVE ACTION NOTIFICATION. USE OF CERTAIN TEST STRIPS WITHIN THIS LOT MAY RESULT IN FALSE POSITIVE PATIENT TEST RESULTS AND POTENTIAL EXPOSURE TO UNNECESSARY TREATMENT OR QUARANTINE.

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 10 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 PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278973 LUMIRADX SARS-COV-2 AG TEST STRIP KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP LUMIRADX UK LTD. 5000229

    Patients

    Seq Age Sex Outcome Treatment
    1