BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    MDR report key: 11837799 · Received May 17, 2021

    Report

    Report Number
    3012642695-2021-01110
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 17, 2021
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS REPORTED TO BE ASYMPTOMATIC WHEN INITIAL LUMIRADX SARS-COV-2 AG TEST WAS PERFORMED ON (B)(6) 2021 WITH STRIP LOT 6000205 AND INSTRUMENT SERIAL NUMBER (B)(4). CONFIRMATORY TESTING WAS PERFORMED VIA POLYMERASE CHAIN REACTION (PCR). THE CONFIRMATORY TEST RESULT WAS POSITIVE. THE CUSTOMER REPORTED THE FOLLOWING PROCESS FOR TESTING ON THE LUMIRADX PLATFORM: "NURSE COLLECTS SWAB, INOCULATE VIAL. THEN ANOTHER NURSE RUNS THE TEST MIXING AND APPLYING ON THE STRIP." THE CUSTOMER REPORTED THEIR CLEANING PRACTICES TO BE "ALCOHOL WIPE AT END OF DAY- NO CLEANING BETWEEN PATIENTS", AND FURTHER REPORTED THAT GLOVES ARE CHANGED AFTER EACH SAMPLE. LOT 6000205 MET ALL DEFINED QC CRITERIA AT THE TIME IT WAS RELEASED AND TESTING USING NEGATIVE NASAL SWABS FROM IN-HOUSE DONORS MEETS EXPECTED PERFORMANCE FOR USE IN THE FIELD. REVIEW OF PRODUCT RISK ASSESSMENT - SARS-COV-2 AG ASSAY REVISION 7, RESULTED IN SEVERITY OF MODERATE, AS FOLLOWS: FAILURE TO SELF-ISOLATE PATIENT AND INSTITUTE APPROPRIATE INFECTION CONTROL MEASURES. NO PATIENT HARM, INJURY OR ADVERSE HEALTH CONSEQUENCES WERE COMMUNICATED BY THE CUSTOMER TO LUMIRADX FOR THE REPORTED DISCORDANT RESULT. TRENDING DATA FOR DISCORDANT RESULTS WAS REVIEWED FOR THIS LOT AND THE OCCURRENCE RATE PER QUANTITY OF STRIPS IN THE FIELD WAS CALCULATED AS (B)(4). LUMIRADX SARS-COV-2 AG TEST PRODUCT INSERT CLAIMS A SENSITIVITY OF 97.6% WITH A REFERENCE RT-PCR ASSAY AND IT IS ACCEPTED THAT UP TO 2.4% OF TEST STRIPS MAY GENERATE A DISCORDANT FALSE NEGATIVE RESULT. 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 FROM THIS LOT 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

    THIS IS REPORT 3 OF 4 FOR THIS FACILITY AND AWARE DATE. THE CUSTOMER REPORTED A SUSPECTED FALSE (INCORRECT) NEGATIVE RESULT FROM A RAPID RESULT COVID TEST SYSTEM ON AN INDIVIDUAL ASYMPTOMATIC PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729823 LUMIRADX SARS-COV-2 AG TEST STRIP KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP LUMIRADX UK LTD. 6000205

    Patients

    Seq Age Sex Outcome Treatment
    1