BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMIRADX SARS-COV-2 AG TEST STRIP KIT

    MDR report key: 11843524 · Received May 18, 2021

    Report

    Report Number
    3012642695-2021-01123
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 18, 2021
    Manufacturer
    LUMIRADX UK LTD.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT TESTING ON INITIAL LUMIRADX SARS-COV-2 AG TEST WAS PERFORMED ON (B)(6) 2021 WITH STRIP LOT 6000196 AND INSTRUMENT SERIAL NUMBER (B)(4). SECONDARY TESTING ON THE LUMIRADX PLATFORM PRODUCED AN POSITIVE RESULT. TERTIARY TESTING WITH THE TESTING PLATFORM ON AN ALTERNATIVE INSTRUMENT (INSTRUMENT SERIAL NUMBER (B)(4)) PROVIDED A NEGATIVE RESULT. SAMPLE COLLECTION AND TESTING FOR LUMIRADX SARS-COV-2 AG WAS REPORTED BY THE CUSTOMER AS FOLLOWS: "NURSE GOES TO PATIENT'S CAR AND CHECKS VITALS. PATIENT SELF-COLLECTS AND PLACES SWAB DIRECTLY INTO BUFFER TUBE. BUFFER TUBE IS LABELLED WITH PATIENT INFORMATION AND IMMEDIATELY BROUGHT INSIDE FOR PROCESSING ON PLATFORM. FOR CARS WITH MULTIPLE PATIENTS (FAMILIES), SAMPLES ARE ALL COLLECTED AND LABELLED AT THE SAME TIME BEFORE BEING BROUGHT INSIDE FOR PROCESSING". THE CUSTOMER REPORTED THEIR CLEANING PRACTICES AS FOLLOWS: "AFTER POSITIVE RESULTS, DEVICE IS CLEANED WITH A BLEACH WIPE AND THEN WITH AN ALCOHOL PAD TO CLEAR RESIDUE LEFT BY BLEACH WIPE. DEVICE IS CLEANED WITH ALCOHOL PAD AT THE BEGINNING AND END OF DAY AS WELL, BUT NOT AFTER NEGATIVE RESULTS", AND FURTHER REPORTED THAT GLOVES ARE CHANGED AFTER EACH SAMPLE. LOT 6000196 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. THERE WAS NO RECORD OF SYMPTOMS FOR THIS PATIENT. THEREFORE, 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. 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 SPECIFICITY OF 96.6% WITH A REFERENCE RT-PCR ASSAY AND IT IS ACCEPTED THAT UP TO 3.4% OF TEST STRIPS MAY GENERATE A DISCORDANT FALSE POSITIVE 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 2 OF 2 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 ASYMPTOMATIC PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739262 LUMIRADX SARS-COV-2 AG TEST STRIP KIT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP LUMIRADX UK LTD. 6000196

    Patients

    Seq Age Sex Outcome Treatment
    1