BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    MDR report key: 13057160 · Received December 21, 2021

    Report

    Report Number
    3012642695-2021-01533
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    December 7, 2021
    Report Date
    December 21, 2021
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT REPORTED AS ASYMPTOMATIC. INITIAL LUMIRADX SARS-COV-2 AG TEST WAS PERFORMED ON (B)(6) 2021 WITH STRIP LOT 6000779. THE INITIAL TEST RESULT WAS NEGATIVE. SECONDARY TESTING WAS PERFORMED TWICE ON THE LUMIRADX PLATFORM WITH STRIP LOT 6000779, BOTH PRODUCED A POSITIVE RESULT. CONFIRMATORY TESTING WAS PERFORMED VIA POLYMERASE CHAIN REACTION (PCR). THE CONFIRMATORY TEST RESULT WAS NEGATIVE. ALL CUSTOMER REPORTED PRODUCT HANDLING PRACTICES ARE CONSISTENT WITH PRODUCT INSERT AND SWABS USED HAVE BEEN VALIDATED FOR USE WITH THE LUMIRADX SARS-COV-2 AG TEST. NO PATIENT HARM, INJURY OR ADVERSE HEALTH CONSEQUENCES WERE COMMUNICATED BY THE CUSTOMER TO LUMIRADX FOR THE REPORTED DISCORDANT RESULT. REVIEW OF PRODUCT RISK ASSESSMENT CONFIRMED THE APPLICABLE RISK CATEGORIES REMAIN APPROPRIATE FOR THE REPORTED EVENT. 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. REVIEW OF TRENDING DATA FOR DISCORDANT RESULTS WAS REVIEWED AND THE OCCURRENCE RATE FOR THE REPORTED STRIP LOT CONTINUES TO DEMONSTRATE FIELD PERFORMANCE WITHIN SPECIFICATION OF PRODUCT CLAIMS, RELATIVE TO THE QUANTITY OF STRIPS IN THE FIELD. ROOT CAUSE DETERMINATION: NO DEFINITIVE ROOT CAUSE HAS BEEN DETERMINED FOR THE REPORTED DISCORDANT RESULT BASED ON THE INFORMATION CURRENTLY AVAILABLE. INVESTIGATION CONCLUSION AND STATUS OF INVESTIGATION: NO FURTHER INVESTIGATION IS CONSIDERED NECESSARY AT THIS TIME. THIS STRIP LOT CONTINUES TO DEMONSTRATE FIELD PERFORMANCE WITHIN SPECIFICATION OF PRODUCT CLAIMS, RELATIVE TO THE QUANTITY OF STRIPS IN THE FIELD. REPORTS OF DISCORDANT RESULTS FOR THIS LOT WILL CONTINUE TO BE TRENDED AND REVIEWED, WITH ACTION TAKEN AS APPROPRIATE IN RESPONSE TO ANY ADVERSE TRENDS OR EVENTS INCLUDING A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    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
    1949188 LUMIRADX SARS-COV-2 AG TEST STRIP KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM, QKP LUMIRADX UK LTD. 6000779

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown LUMIRADX SMART DIAGNOSTIC PLATFORM