BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16591536 · Received March 22, 2023

    Report

    Report Number
    3002777243-2023-00002
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    November 28, 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 3/4/2023 CUSTOMER UNIVERSITY OF (B)(6) REPORTED A FALSE NEGATIVE RESULT ON LOT IK056C- 0014 OF NXTAG RPP+SARS COV-2 IVD-EUA ASSAY (PN: I056C0468) FROM A RUN PERFORMED ON (B)(6) 2022. THE ASSAY WAS BEING USED FOR A COLLEGE OF AMERICAN PATHOLOGISTS (CAP) SURVEY AND NOT TO TEST PATIENT SAMPLES OR REPORT RESULTS AS STATED BY THE CUSTOMER. IT WAS REPORTED THAT INFLUENZA A H1 TARGET WAS MISSED IN THE FIRST RUN. NO REPEATS WERE PERFORMED AS NO MORE SAMPLE WAS AVAILABLE. THERE WERE 5 SAMPLES RUN AS PART OF THE CAP SURVEY AND THE FALSE NEGATIVE ON INFLUENZA A H1 WAS ONLY IDENTIFIED IN 1 RUN. TECHNICAL SUPPORT AND FQA REVIEWED THE DATA PROVIDED BY THE CUSTOMER: BEAD COUNT AND MS2 VALUES WERE WITHIN SPECIFICATION BUT LOW MEAN FLUORESCENT INTENSITIES (MFI) WERE NOTICED ON FLU A, H1, H1N1 AND H3. QC RELEASE DATA WAS REVIEWED FOR THE PLATE LOT BT056C-1019 THAT IS UNDER KIT LOT IK056C-0014 AND NO DISCREPANCIES WERE NOTED. ALL TARGETS PASSED. DEVICE REVIEW: MAGPIX INSTRUMENT SN: (B)(4), A REVIEW OF PAST 12 MONTHS OF COMPLAINTS DATA AND WORK ORDERS SHOWED 3 CASES AS FOLLOWS: 1. CASE#: (B)(4) (REPORTED 2/7/2023): VERIFICATION FAILURE WAS NOTED. A FIELD SERVICE ENGINEER (FSE) WENT OUT TO REPLACE THE SAMPLE PROBE THAT FIXED THE PROBLEM. THIS ISSUE IS UNRELATED TO THE CURRENT COMPLAINT. 2. CASE#: (B)(4) (REPORTED 1/25/2023): VERIFICATION FAILURE ISSUE WHERE FSE WAS SENT OUT AND A CLEANING PROCEDURE WAS PERFORMED. THIS ISSUE IS UNRELATED TO THE CURRENT COMPLAINT. 3. CASE#: (B)(4) (REPORTED 8/4/2022): INVALID CALLS WHEN RUNNING XTAG GPP ASSAY. MOLECULAR APPLICATIONS SPECIALIST (MAS) ROOT CAUSED THE ISSUE TO WORKFLOW TECHNIQUE USED AT THE CUSTOMER SITE. CONSUMABLE REVIEW: A HISTORICAL REVIEW FOR PAST 12 MONTHS WAS PERFORMED, I.E. 3/6/2022 TO 3/6/2023 ON IMPACTED LOT IK056C-0014. ONLY 1 CASE#: (B)(4) WAS REPORTED ON 6/23/2022 FOR AN ERROR ON THE USB SHIPPED WITH THE LOT WHICH IS UNRELATED TO THE CURRENT SITUATION. NO NCMR WAS REPORTED AS OF 3/10/2023 ON THIS LOT EITHER. SAMPLE WORK-UP: LUMINEX TECHNICAL SUPPORT INTERVIEWED THE CUSTOMER ABOUT THE SAMPLE PREPARATION TECHNIQUES AND NO DISCREPANCIES IN THE PROCESS WERE FOUND. HOWEVER, THE RUN IS FROM (B)(6) 2022 AND THE CUSTOMER COULD NOT CONFIRM THE METHODS USED AT THE TIME OF THE EVENT. NO OTHER ISSUES HAVE BEEN OBSERVED EVER SINCE. CONCLUSION: THE ROOT CAUSE OF THE DISCREPANT RESULT COULD NOT BE CONFIRMED PER THE CUSTOMER-PROVIDED INFORMATION. THE ISSUE IS LIMITED TO ONLY 1 KIT OF THE IMPACTED LOT, IK056C-0014 USED AT THE COMPLAINT CUSTOMER SITE. SINCE (B)(4) WERE SOLD TO VARIOUS DIFFERENT CUSTOMERS AND NO COMPLAINTS RECEIVED, THIS 1 INCIDENT MAY BE DUE TO THE ASSAY CONCENTRATION BEING BELOW THE LIMIT OF DETECTION AS CAP SURVEY SAMPLES HAVE DIFFERENT TITER LEVELS THAN THE LUMINEX ASSAYS. KIT LOT HAS EXPIRED AS OF 12/31/2022 SO THERE IS NO FURTHER SCOPE OF FALSE RESULTS. NO INTERNAL NONCONFORMANCE WAS FOUND ON THIS LOT. THERE IS NO PATIENT IMPACT AS THE SAMPLE WAS RUN FOR A CAP SURVEY AND NOT TO REPORT AND PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903589 NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2 (IVD EUA) NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2 (IVD EUA) QLT LUMINEX MOLECULAR DIAGNOSTICS, INC. IK056C-0014

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown