BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    MDR report key: 11645247 · Received April 9, 2021

    Report

    Report Number
    3012642695-2021-00599
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    January 13, 2021
    Report Date
    December 14, 2021
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT REPORTED AS ASYMPTOMATIC. INITIAL LUMIRADX SARS-COV-2 AG TEST WAS PERFORMED AS A POOLED TEST (2 PATIENTS' SWABS SHARING THE SAME EXTRACTION BUFFER) ON (B)(6) 2021 WITH STRIP LOT 5000181 (REFER TO MDR REPORT NUMBER 3012642695-2021-00600, FOR ADDITIONAL POOLED PATIENT). THE INITIAL POOLED TEST RESULT WAS POSITIVE. SECONDARY TESTING ON THE LUMIRADX PLATFORM WITH STRIP LOT 5000181, PERFORMED ON AN INDIVIDUAL BASIS WITH NEW SWAB SAMPLES, PRODUCED A NEGATIVE RESULT. LUMIRADX SARS-COV-2 AG TEST PRODUCT IS NOT INTENDED FOR USE IN POOLED TESTING AND THE SWABS USED HAVE NOT BEEN VALIDATED FOR POOLED TESTING WITH LUMIRADX TEST PRODUCTS. LUMIRADX SARS-COV-2 AG TEST PRODUCT INSERT IDENTIFIES THAT SAMPLES MUST BE PROCESSED AS INDICATED IN THE "SAMPLE EXTRACTION" AND "PERFORMING A TEST" SECTIONS OF THE PRODUCT INSERT. FAILURE TO FOLLOW THE INSTRUCTIONS FOR USE CAN RESULT IN INACCURATE RESULTS. NO PATIENT HARM, INJURY OR ADVERSE HEALTH CONSEQUENCES WERE COMMUNICATED BY THE CUSTOMER TO LUMIRADX FOR THE REPORTED DISCORDANT RESULT. A REVIEW OF THE PRODUCT RISK ASSESSMENT CONFIRMED THE APPLICABLE RISK CATEGORIES REMAIN APPROPRIATE FOR THE REPORTED EVENT. A REVIEW OF MANUFACTURING RECORDS IDENTIFIED THAT THE REPORTED STRIP LOT MET ALL DEFINED QC CRITERIA AT THE TIME IT WAS RELEASED, AND THAT IN-HOUSE TESTING CONFIRMED STRIP LOT MET EXPECTED PERFORMANCE CRITERIA FOR USE IN THE FIELD. TRENDING DATA FOR DISCORDANT RESULTS WERE REVIEWED AND THE OCCURRENCE RATE FOR THE REPORTED STRIP LOT DEMONSTRATED FIELD PERFORMANCE WITHIN SPECIFICATION OF PRODUCT CLAIMS, UNTIL EXPIRY, RELATIVE TO THE QUANTITY OF STRIPS IN THE FIELD WHEN USED ACCORDING TO THE IFU. ROOT CAUSE DETERMINATION: THE MOST LIKELY ROOT CAUSE FOR THE REPORTED FALSE POSITIVE, HAS BEEN DETERMINED AS CONSUMER MISUSE OF PRODUCT OUT WITH LABELLING GUIDELINES AS FOUND IN THE IFU. HOWEVER, WHEN USED CORRECTLY AND WITHIN LABELLING GUIDELINES FOR TESTING INDIVIDUAL PATIENT SAMPLES, LUMIRADX SARS-COV-2 AG TEST PRODUCT PERFORMED AS EXPECTED. INVESTIGATION CONCLUSION AND STATUS OF INVESTIGATION: NO FURTHER INVESTIGATION IS CONSIDERED NECESSARY AT THIS TIME. THIS STRIP LOT WAS USED WITHIN THE FIELD UNTIL EXPIRY AND DEMONSTRATED FIELD PERFORMANCE WITHIN SPECIFICATION OF PRODUCT CLAIMS, RELATIVE TO THE QUANTITY OF STRIPS IN THE FIELD.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A "CATCH-UP REPORT" ACTION IDENTIFIED BY FDA ON 21 JANUARY 2021. REPORTS OF ACTIVE MDRS WERE PROCESSED FIRST TO ENSURE ON-TIME SUBMISSION AHEAD OF THIS CATCH-UP REPORT. THIS IS REPORT 7 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. REPEAT TESTING OF THE NASAL SWAB SAMPLE WITH THE TESTING PLATFORM PRODUCED A NEGATIVE RESULT. CONFIRMATORY TESTING OF THE PATIENT VIA POLYMERASE CHAIN REACTION (PCR) TESTING WAS NEGATIVE. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME, AS THIS EVENT DOES NOT CONTRIBUTE TO A SIGNIFICANT DEVIATION FROM THE ESTABLISHED PERFORMANCE CHARACTERISTICS OF THE PRODUCT.

    Description of Event or Problem · 1

    THIS IS REPORT 7 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
    542718 LUMIRADX SARS-COV-2 AG TEST STRIP KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP LUMIRADX UK LTD. 5000181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CITOSWAB NASAL SWAB| LUMIRADX SMART DIAGNOSTIC PLATFORM| NASAL SWAB