BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    MDR report key: 11372317 · Received February 24, 2021

    Report

    Report Number
    3012642695-2021-00017
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    January 23, 2021
    Report Date
    February 23, 2021
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QKP
    Removal / Correction Number
    Z-1132-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS REPORT 5 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 AN ASYMPTOMATIC PATIENT. NO FURTHER PATIENT DATA WAS AVAILABLE. CONFIRMATORY TESTING OF THE PATIENT VIA POLYMERASE CHAIN REACTION (PCR) TESTING WAS NEGATIVE. A PRODUCT RECALL TO REMOVE LOT 5000265 FROM SERVICE WAS CONDUCTED DUE TO OBSERVATIONS OF A HIGHER POTENTIAL FOR FALSE POSITIVE RESULTS OVER OTHER LOTS. 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 WITH THE RECALL NOTIFICATION. USE OF THESE TEST STRIP LOTS 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 5 OF 10 FOR THIS FACILITY AND AWARE DATE. THE CUSTOMER REPORTED A SUSPECTED FALSE (INCORRECT) POSITIVE RESULT FROM A RAPID COVID TEST SYSTEM ON AN ASYMPTOMATIC PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271097 LUMIRADX SARS-COV-2 AG TEST STRIP KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP LUMIRADX UK LTD. 5000265

    Patients

    Seq Age Sex Outcome Treatment
    1