BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    MDR report key: 12598355 · Received October 8, 2021

    Report

    Report Number
    3012642695-2021-01365
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 8, 2021
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HEALTH STATUS WAS NOT REPORTED. FOLLOWING INITIAL LUMIRADX SARS-COV-2 AG TEST PERFORMED ON (B)(6) 2021 WITH STRIP LOT 6000416 (3012642695-2021-01364 REFERS), GIVING AN INITIAL POSITIVE RESULT. SECONDARY TESTING USING LUMIRADX SARS-COV-2 AG TEST WAS PERFORMED ON (B)(6) 2021 WITH STRIP LOT 6000594. THE SECONDARY TEST RESULT WAS POSITIVE. CONFIRMATORY TESTING WAS PERFORMED VIA POLYMERASE CHAIN REACTION (PCR). THE CONFIRMATORY TEST RESULT WAS NEGATIVE. CUSTOMER REPORTED PRODUCT HANDLING PRACTICES IDENTIFIED THE USE OF "PURITAN" AND "FOAM TECH MEDICAL" SWABS THAT HAVE NOT BEEN VALIDATED FOR USE WITH THE LUMIRADX SARS-COV-2 AG TEST PRODUCT. IN ADDITION, THERE WAS LACK OF INFORMATION PROVIDED TO CONFIRM THAT INSTRUMENT CLEANING PRACTICES WERE CONSISTENT WITH PRODUCT INSERT GUIDANCE. 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 PRACTICES WERE SUFFICIENT TO PREVENT THE POTENTIAL FOR CROSS-CONTAMINATION, IN ADDITION THE CUSTOMER USED SWABS THAT WERE NON-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 · 1

    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
    1497607 LUMIRADX SARS-COV-2 AG TEST STRIP KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM, QKP LUMIRADX UK LTD. 6000594

    Patients

    Seq Age Sex Outcome Treatment
    1 FOAMTECHMEDICAL SWAB| LUMIRADX SMART DIAGNOSTIC PLATFORM| PURITAN SWAB