BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2 (IVD EUA)

    MDR report key: 16591470 · Received March 22, 2023

    Report

    Report Number
    3002777243-2023-00001
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    June 21, 2022
    Report Date
    March 22, 2023
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS, INC
    Product Code
    QLT
    PMA / PMN Number
    EUA210031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTICS TESTS AND PER THE CONDITIONS OF THE EMERGENCY USE AUTHORIZATION, SUSPECTED FALSE NEGATIVES, FALSE POSITIVES AND SIGNIFICANT DEVIATIONS IN EXPECTED PERFORMANCE CHARACTERISTICS WILL BE REPORTED UNDER 21 CFR 803. THE ALLEGED FALSE TEST RESULTS IN THIS EVENT HAVE NOT CAUSED PATIENT INJURY OR DEATH; HOWEVER, THIS EVENT IS BEING REPORTED CONSERVATIVELY BECAUSE IF THE ALLEGED MALFUNCTION WERE TO RECUR THERE IS A NON-REMOTE POTENTIAL FOR SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 0

    DATA REVIEW: ON (B)(6) 2022 (B)(6) UNIVERSITY REPORTED FALSE POSITIVE RESULTS ON LOT IK056C-0017 OF NXTAG RPP+SARS COV-2 IVD-EUA ASSAY (PN: I056C0468). THE ASSAY WAS BEING USED FOR RUO PURPOSES AS STATED BY THE CUSTOMER AND NOT TO TEST PATIENT SAMPLES OR REPORT RESULTS. HOWEVER, A PRE/HRA ASSESSMENT IS BEING PERFORMED ON 3/9/2023 PER FDA GUIDELINES ON EUA PRODUCT. CUSTOMER CONFIRMED DISCREPANT RESULT AFTER PERFORMING COMPARATIVE METHODS INCLUDING THE PYLES PCR ASSAY AND THE ABBOTT ID NOW ASSAY. LUMINEX MOLECULAR APPLICATION SPECIALIST REVIEWED THE 2 COMPARATIVE METHODS AS FOLLOWS: PYLES PCR ASSAY: PERFORMANCE SPECIFICATIONS UNKNOWN BY MAS DIRECTOR ABOTT ID NOW: IS MUCH LESS SENSITIVE THAN NXTAG. FOR EXAMPLE, THE LOD ESTABLISHED WITH THE FDA REFERENCE PANEL WAS 300,000 NDU/ML FOR ABOTT ID NOW AND 5400 NDU/ML FOR NXTAG COV STANDALONE. TECHNICAL SUPPORT AND MAS REVIEWED THE DATA PROVIDED BY THE CUSTOMER: DATA SHOWED MULTIPLE COV POSITIVES THAT DID NOT CORRELATE WITH OTHER COMPETITOR ASSAYS. CUSTOMER DATA ALSO SAW MULTIPLE RSV A POSITIVE RESULTS. CUSTOMER ACKNOWLEDGED NO CHANGE TO CONSUMABLES OR WORKFLOW AND THAT THE SAME LOT OF RUO NXTAG RPP+SARS COV IS BEING USED. IT WAS RECOMMENDED TO THE CUSTOMER TO TEST FOR ANY DEVICE OR ENVIRONMENTAL CONTAMINATION. THE 2 RUNS WERE EVALUATED AS FOLLOWS: INSTRUMENT SN USED: (B)(4). EVALUATION: BACKGROUNDS ARE LOW BEAD COUNT ISSUES ON THE LAST WELL ("NEG") INVALIDATES RUN LOTS OF IC FAILURES IN BEGINNING OF RUN MANY COV AND RSVA POSITIVES. INSTRUMENT SN USED: (B)(4). EVALUATION: LOW BACKGROUNDS, GOOD IC SIGNALS NEG CTRL FINE- NO BEAD COUNT ISSUES OBSERVED THIS TIME MANY COV POSITIVES AND RSV A POSITIVES. DEVICE REVIEW: MAGPIX INSTRUMENT SN: (B)(4). A REVIEW OF PAST 6 MONTHS OF COMPLAINTS DATA AND WORK ORDERS DID NOT REVEAL ANY SERVICE ACTIONS ON THIS DEVICE THAT MAY CONTRIBUTE TO THE DISCREPANT RESULTS SEEN. CONSUMABLE REVIEW: A COMPLAINT CASE REVIEW FROM 6 MONTHS BEFORE THIS COMPLAINT CASE UNTIL THE EXPIRATION DATE OF THE LOT, I.E.(B)(6) 2022 TO (B)(6) 2022 WAS PERFORMED ON IMPACTED LOT IK056C-0017. ONLY 1 CASE 01382154 WAS REPORTED ON (B)(6) 2022 FROM THE SAME CUSTOMER FOR HIGH RATE OF MS2 FAILURES. THE CASE WAS CONCLUDED TO BE A CAUSE OF ENVIRONMENTAL CONTAMINATION CONFIRMED BY A WIPE TEST AND WAS FOUND TO BE THE SAME ROOT CAUSE OF THE CURRENT COMPLAINT. NO NCMR WAS REPORTED AS OF (B)(6) 2023 ON THIS LOT EITHER. SAMPLE WORK-UP: NO DISCREPANCIES IN THE SAMPLE PREPARATION PER THE PACKAGE INSERT WERE IDENTIFIED EXCEPT THAT A FAULTY THERMAL CYCLER WAS BEING USED AND THERE WAS PRESENCE OF CONTAMINANTS IN THE ENVIRONMENT. MAS WENT ON SITE TO EXAMINE THE CUSTOMER'S WORKFLOW AND PERFORM ASSAY RETRAINING (SEE TASK "NXTAG RPP+COV TRAINING AND TROUBLESHOOTING" WITHIN CASE (B)(4). MAS CONFIRMED LAB CONTAMINATION BY WAY OF WIPE TESTS. MAS PROVIDED MULTIPLE WORKFLOW RECOMMENDATIONS TO ENSURE UNIDIRECTIONAL WORKFLOW AND TO MINIMIZE THE RISK OF CONTAMINATION. THE LAB WAS UTILIZING MANY UN-RECOMMENDED PRACTICES. MAS ALSO PROVIDED NXTAG MAGPIX MAINTENANCE BEST PRACTICES. MAS EXPLAINED TO CUSTOMER THAT WHEN COMPARING RESULTS BETWEEN DIFFERENT ASSAY PLATFORMS, IT IS IMPORTANT TO REMEMBER THAT ALL ASSAYS HAVE DIFFERENT SENSITIVITIES. THIS COULD CAUSE RESULTS TO SEEM DISCREPANT, BUT THE ASSAY JUST MIGHT NOT BE SENSITIVE ENOUGH/TOO SENSITIVE TO PICK UP THE TARGET. IT IS ALSO IMPORTANT TO HAVE AN ALIQUOT FROM THE SAME COLLECTION DATE TESTED BY ANOTHER PCR METHOD TO CONFIRM THE RESULTS. SEE SECONDARY CASE (B)(4) (MS2 FAILURES) FOR ADDITIONAL NXTAG RPP+SARS-COV-2 TROUBLESHOOTING AT THIS SITE. CONCLUSION: THE ROOT CAUSE OF THE DISCREPANT RESULTS WAS FOUND TO BE ENVIRONMENT CONTAMINATION CONFIRMED BY A WIPE TEST AND THE USE OF A FAULTY THERMAL CYCLER. THERE ARE NO NCMR'S ASSOCIATED WITH THE LOT UTILIZED. THERE IS NO INDICATION OF CONSUMABLE OR HARDWARE MALFUNCTION. HOWEVER, PER THE FDA GUIDELINE ON HANDLING OF ANY FALSE RESULTS ON EUA ASSAY, HRA-23-0005 HAS BEEN INITIATED ON(B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436255 NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2 (IVD EUA) NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2 (IVD EUA) QLT LUMINEX MOLECULAR DIAGNOSTICS, INC IK056C-0017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown