BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    MDR report key: 11760452 · Received May 3, 2021

    Report

    Report Number
    3012642695-2021-01011
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    February 9, 2021
    Report Date
    June 28, 2021
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QKP
    Removal / Correction Number
    Z-1132-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WAS REPORTED TO BE ASYMPTOMATIC WHEN INITIAL LUMIRADX SARS-COV-2 AG TEST WAS PERFORMED ON (B)(6) 2021 WITH STRIP LOT 5000265. CONFIRMATORY TESTING WAS PERFORMED THREE TIMES VIA POLYMERASE CHAIN REACTION (PCR). ALL THREE CONFIRMATORY TEST RESULTS WERE NEGATIVE. REVIEW OF PRODUCT RISK ASSESSMENT - SARS-COV-2 AG ASSAY REVISION 7, RESULTED IN SEVERITY OF MINOR, AS FOLLOWS: ASYMPTOMATIC PATIENTS COULD EXPERIENCE SECONDARY HARM OF UNNECESSARY SELF-ISOLATION AND POSSIBLE STRESS/ANXIETY. NO PATIENT HARM, INJURY OR ADVERSE HEALTH CONSEQUENCES WERE COMMUNICATED BY THE CUSTOMER TO LUMIRADX FOR THE REPORTED DISCORDANT RESULT. THE PATIENT REPORTED THAT THE SUSPECTED FALSE POSITIVE RESULT HAD A "NEGATIVE IMPACT" ON HIS MENTAL HEALTH DUE TO "UNNECESSARY ISOLATION". ROOT CAUSE DETERMINATION: SEE BELOW. INVESTIGATION CONCLUSION AND STATUS OF INVESTIGATION: A PRODUCT RECALL TO REMOVE THIS LOT FROM SERVICE WAS CONDUCTED DUE TO OBSERVATIONS OF A HIGHER POTENTIAL FOR FALSE POSITIVE RESULTS.A ROOT CAUSE ANALYSIS AND CORRECTIVE/PREVENTIVE ACTION PLAN SUMMARY WAS PERFORMED AND IMPLEMENTED UNDER DOCUMENT NUMBERS-QA-REP-01338 AND WAS SUBMITTED TO SUPPORT THE RECALL NOTIFICATION. USE OF THESE TEST STRIPS WITHIN THIS LOT MAY RESULT IN FALSEPOSITIVE PATIENT TEST RESULTS AND POTENTIAL EXPOSURE TO UNNECESSARY TREATMENT OR QUARANTINE. IT WAS CONFIRMED THAT LOT 5000265 (GM2000218) MET ALL RELEASE CRITERIA. 228 RELEASED KITS (10,944 TEST STRIPS) OF LOT 5000265 WERE SHIPPED TO CUSTOMERS GLOBALLY BETWEEN (B)(6) 2021 AND (B)(6) 2021. 140 OF THE 228 KITS (6,720 TEST STRIPS) WERE SHIPPED TO CUSTOMERS WITHIN THE UK BETWEEN (B)(6) 2021 AND (B)(6) 2021. THE LOT WAS WITHDRAWN FROM THE FIELD DUE TO INCREASED RISK OF FALSE POSITIVES WITHIN A SPECIFIC SECTION OF THE LOT. FURTHER INFORMATION ON THE SPECIFIC STRIP USED TO TEST THE PATIENT REPORTING THE FALSE POSITIVE RESULT COULD NOT BE OBTAINED TO CONFIRM WHETHER IT WAS WITHIN THE SECTION OF THE BATCH IMPACTED BY THE MANUFACTURING ISSUE.

    Additional Manufacturer Narrative · 1

    THE ASYMPTOMATIC REPORTED A SUSPECTED FALSE (INCORRECT) POSITIVE RESULT FROM A RAPID RESULT COVID TEST SYSTEM. THE LOT NUMBER WAS NOT KNOWN. CONFIRMATORY TESTING OF THE PATIENT VIA POLYMERASE CHAIN REACTION (PCR) TESTING WAS PERFORMED THREE TIMES - EACH RESULT WAS NEGATIVE. THIS PRODUCT IS A SINGLE-USE ITEM CONTAINING A PATIENT'S BIOLOGICAL SAMPLE AND WAS THEREFORE NOT AVAILABLE FOR ROOT-CAUSE EVALUATION. BECAUSE THE LOT NUMBER COULD NOT BE OBTAINED A TRENDING EVALUATION COULD NOT BE PERFORMED FOR THIS EVENT. HOWEVER, QC TESTING IS PERFORMED ON ALL LOTS OF THIS PRODUCT AT THE TIME OF MANUFACTURING AND ONLY LOTS THAT MEET SPECIFICATIONS ARE RELEASED FOR DISTRIBUTION. NO ROOT CAUSE HAS BEEN DETERMINED AT THIS TIME. 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. THERE WERE NO PATIENT ADVERSE EVENTS ASSOCIATED WITH THIS REPORT.

    Description of Event or Problem · 1

    THE ASYMPTOMATIC REPORTED A SUSPECTED FALSE (INCORRECT) POSITIVE RESULT FROM A RAPID RESULT COVID TEST SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660198 LUMIRADX SARS-COV-2 AG TEST STRIP KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP LUMIRADX UK LTD. 5000265

    Patients

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