BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    MDR report key: 12983629 · Received December 13, 2021

    Report

    Report Number
    3012642695-2021-01499
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    January 18, 2021
    Report Date
    December 13, 2021
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QKP
    Removal / Correction Number
    Z-1312-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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 5000223 (REFER TO MDR REPORT NUMBER 3012642695-2021-01500, FOR ADDITIONAL POOLED PATIENT). THE INITIAL POOLED TEST RESULT WAS POSITIVE. REPEAT TESTING ON THE LUMIRADX PLATFORM WITH STRIP LOT 5000223, PERFORMED USING THE SAME POOLED BUFFER SAMPLE, PRODUCED A NEGATIVE RESULT. FINAL TESTING ON THE LUMIRADX PLATFORM WITH STRIP LOT 5000223, 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: STRIP LOT WAS ALSO SUBJECT TO FIELD CORRECTION, IN THE FORM OF AN INSTRUMENT SOFTWARE UPDATE, AS DOCUMENTED UNDER FDA RECALL Z-1312-2021, TO CORRECT A MANUFACTURING ISSUE (VALVE RUN OUT) THAT WAS ATTRIBUTED WITH AN INCREASED RISK OF FALSE POSITIVES IN A CERTAIN PORTION OF STRIPS WITHIN THE LOT. NO FURTHER INVESTIGATION IS CONSIDERED NECESSARY AT THIS TIME. THE REMAINING STRIPS FROM THE LOT THAT WERE NOT SUBJECT TO THE FIELD CORRECTION, WERE USED WITHIN THE FIELD UNTIL EXPIRY AND DEMONSTRATED FIELD PERFORMANCE WITHIN THE SPECIFICATION OF PRODUCT CLAIMS, RELATIVE TO THE QUANTITY OF STRIPS IN THE FIELD.

    Description of Event or Problem · 0

    THIS IS REPORT 13 OF 28 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
    1887778 LUMIRADX SARS-COV-2 AG TEST STRIP KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM, QKP LUMIRADX UK LTD. 5000223

    Patients

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