BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    MDR report key: 11820930 · Received May 13, 2021

    Report

    Report Number
    3012642695-2021-01085
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 13, 2021
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QKP
    Removal / Correction Number
    Z-1312-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS REPORTED TO BE SYMPTOMATIC WHEN INITIAL LUMIRADX SARS-COV-2 AG TEST WAS PERFORMED ON (B)(6) 2021 WITH STRIP LOT 6000091 AND INSTRUMENT SERIAL NUMBER (B)(4). SECONDARY TESTING ON THE LUMIRADX PLATFORM PRODUCED A NEGATIVE RESULT. THE CUSTOMER REPORTED THE FOLLOWING PROCESS FOR TESTING ON THE LUMIRADX PLATFORM: "ONE SAMPLE [COLLECTED AND PREPARED AT A TIME], NASAL, DIRECT TESTING." THE CUSTOMER REPORTED THEIR CLEANING PRACTICES TO BE "AS RECOMMENDED BY [THE MANUFACTURER]", AND FURTHER REPORTED THAT GLOVES ARE CHANGED AFTER EACH SAMPLE. LOT 6000091 MET ALL DEFINED QC CRITERIA AT THE TIME IT WAS RELEASED AND TESTING USING NEGATIVE NASAL SWABS FROM IN-HOUSE DONORS MEETS EXPECTED PERFORMANCE FOR USE IN THE FIELD. REVIEW OF PRODUCT RISK ASSESSMENT - SARS-COV-2 AG ASSAY REVISION 7, RESULTED IN SEVERITY OF MODERATE, AS FOLLOWS: DELAYED DIAGNOSIS LEADING TO DELAYED TREATMENT OF THE TRUE CAUSE OF THE PATIENT'S SYMPTOMS. UNNECESSARY ISOLATION. NO PATIENT HARM, INJURY OR ADVERSE HEALTH CONSEQUENCES WERE COMMUNICATED BY THE CUSTOMER TO LUMIRADX FOR THE REPORTED DISCORDANT RESULT. TRENDING DATA FOR DISCORDANT RESULTS WAS REVIEWED FOR THIS LOT AND THE OCCURRENCE RATE PER QUANTITY OF STRIPS IN THE FIELD WAS CALCULATED AS (B)(4). LUMIRADX SARS-COV-2 AG TEST PRODUCT INSERT CLAIMS A SPECIFICITY OF 96.6% WITH A REFERENCE RT-PCR ASSAY AND IT IS ACCEPTED THAT UP TO 3.4% OF TEST STRIPS MAY GENERATE A DISCORDANT FALSE POSITIVE RESULT. ROOT CAUSE DETERMINATION: SEE BELOW. INVESTIGATION CONCLUSION AND STATUS OF INVESTIGATION: A FIELD CORRECTIVE ACTION IN THE FORM OF AN INSTRUMENT SOFTWARE UPDATE WAS ISSUED TO ADDRESS THIS LOT 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) 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 5 OF 6 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
    712914 LUMIRADX SARS-COV-2 AG TEST STRIP KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP LUMIRADX UK LTD. 6000091

    Patients

    Seq Age Sex Outcome Treatment
    1