BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    MDR report key: 12826926 · Received November 17, 2021

    Report

    Report Number
    3012642695-2021-01446
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 14, 2021
    Report Date
    November 17, 2021
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT REPORTED AS SYMPTOMATIC. INITIAL LUMIRADX SARS-COV-2 AG TEST WAS PERFORMED ON (B)(6) 2021 WITH STRIP LOT 6000746. THE INITIAL TEST RESULT WAS POSITIVE. CONFIRMATORY TESTING WAS PERFORMED VIA POLYMERASE CHAIN REACTION (PCR). THE CONFIRMATORY TEST RESULT WAS NEGATIVE. CUSTOMER PROVIDED NO FURTHER INFORMATION RELATED TO THE COMPLAINT INCIDENT. REVIEW OF AVAILABLE COMPLAINT DATA COULD NOT CONFIRM THAT PRODUCT AND INSTRUMENT USE WERE CONSISTENT WITH RELATED PRODUCT INSERT GUIDANCE, AS INSUFFICIENT INFORMATION WAS PROVIDED IN RELATION TO GLOVE CHANGE PROTOCOLS, PRODUCT AND INSTRUMENT HANDLING AND CLEANING PRACTICES OR THAT SWABS USED FOR SAMPLE COLLECTION WERE VALIDATED FOR USE WITH LUMIRADX SARS-COV-2 AG TEST PRODUCT. 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. HOWEVER, THERE WAS INSUFFICIENT DATA TO CONFIRM THAT INSTRUMENT CLEANING AND GLOVING PRACTICES WERE APPROPRIATE TO PREVENT THE POTENTIAL FOR CROSS-CONTAMINATION, IN ADDITION THE CUSTOMER DID NOT PROVIDE DETAILS OF SWABS USED FOR SAMPLE COLLECTION, TO CONFIRM THEY WERE VALIDATED FOR USE WITH LUMIRADX SARS-COV-2 AG TEST PRODUCT. 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

    THIS IS REPORT 11 OF 14 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
    1728574 LUMIRADX SARS-COV-2 AG TEST STRIP KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM, QKP LUMIRADX UK LTD. 6000746

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown LUMIRADX SMART DIAGNOSTIC PLATFORM