BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2 (IVD- EUA) 96 TESTS

    MDR report key: 16718787 · Received April 11, 2023

    Report

    Report Number
    3002777243-2023-00003
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    January 31, 2022
    Report Date
    April 11, 2023
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS, INC.
    Product Code
    QLT
    PMA / PMN Number
    EUA210031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 9/1/2022 CUSTOMER, BEAUMONT HOSPITAL-ROYAL OAK REPORTED THAT THEY FAILED TO DETECT HUMAN METAPNEUMOVIRUS (HMPV) AND SAW LOW SIGNALS ON INFLENZA B, PIV3 AND L. PNEUMO IN 2 RUNS OF NXTAG RPP+SARS-COV-2 EUA ASSAY (PN: I056C0468, LOT IK056C-0018). HOWEVER, THE MS2 TARGET (INTERNAL CONTROL) WAS CONSISTENTLY GENERATED WITH STRONG SIGNALS WHICH IS UNUSUAL IN SUCH A SCENARIO. CUSTOMER REPORTED THAT THEY ARE USING ZEPTOMETRIX CONTROL POOL 4 (EXTERNAL POSITIVE CONTROLS) ON THE ASSAY WHERE THEY'RE ENCOUNTERING DETECTION ISSUES. DURING THE COMPLAINT INVESTIGATION, IT WAS NOTED THAT THE CUSTOMER HAD RECEIVED THE SAME LOT OF NXTAG RPP+SARS-COV-2 EUA ASSAY IN A SHIPMENT RIGHT BEFORE AND NO COMPLAINTS WERE REPORTED. SHIPPING ISSUES WERE ALSO RULED OUT. ON 10/8/2022, LUMINEX QUALITY CONTROL CONDUCTED AN INVESTIGATION ON THE RETENTION KITS OF LOT IK056C-0018. VARIOUS ANALYTES INCLUDING HMPV, FLUB, PARA3 AND L. PNEUMOVIRUS (ANALYTES IN THE ZEPTO POOL 4 CONTROL) AND MS2 WERE RUN. QC ALSO RAN REFERENCE KIT LOT IK056C-0021 FOR COMPARISON. BOTH KIT LOTS PERFORMED WITHIN THE REQUIRED SPECIFICATIONS FOR ALL 4 TARGETS CAPTURED IN THE ZEPTO POOL 4 MATRIX BY THE CUSTOMER. REFERENCE TEAM TASK, T-00027537. ON (B)(6) 2022, LUMINEX MOLECULAR APPLICATIONS SPECIALIST RAN KIT LOT IK056C-0018 AND KIT LOT IK056C-0020 AND FOUND THAT BOTH LOTS GAVE SIMILAR RESULTS. IT WAS CONCLUDED THAT THE REMAINING 14 KITS OF LOT IK056C-0018 SHOULD BE FINE TO USE BY THE CUSTOMER AS NO DISCREPANCIES HAVE BEEN IDENTIFIED. THE ROOT CAUSE FOR THE COMPLAINT 2 RUNS COULD NOT BE CONCLUDED AS THE ISSUE WAS NOT REPEATED INTERNALLY OR AT CUSTOMER SITE. POTENTIAL CAUSE CAN BE SAMPLE PREPARATION OR POSSIBLE THAT THE ZEPTO POOL 4 HAD AN ISSUE. CONSUMABLE REVIEW: 12 MONTH HISTORICAL REVIEW ON LOT IK056C-0018 SHOWED 1 PAST CASE, 01379309 REPORTED BY A DIFFERENT CUSTOMER ON INVALID RESULTS DUE TO LOW BEAD COUNTS. HOWEVER, INVESTIGATION REVEALED THAT THE ISSUE WAS RELATED TO CUSTOMER'S LAB ACTIVITIES AND NOT TO THE PRODUCT. THEREFORE, THIS COMPLAINT IS UNRELATED. DEVICE REVIEW: MAGPIX SN: (B)(4) A 12 MONTH HISTORICAL REVIEW SHOWED 4 CASES THAT HAD BEEN REPORTED ON THIS SERIAL NUMBER: CASES (B)(4). NONE OF THESE CASES WERE RELATED TO THIS ISSUE SINCE THEY WERE ALL NON-REPORTABLE HARDWARE ONLY PROBLEMS. CONCLUSION: BASED ON THE CUSTOMER PROVIDED DATA, HISTORICAL REVIEWS AND LUMINEX INVESTIGATION, NO RISK TO PATIENT HEALTH HAS BEEN DETERMINED. THIS DISCREPANT RESULT WAS FOUND BY THE CUSTOMER WHEN RUNNING CONTROLS. THERE IS NO ALLEGATION OF A FALSE RESULT ON A PATIENT SAMPLE. THE ISSUE COULD NOT BE REPRODUCED IN HOUSE AND THEREFORE WOULD BE HANDLED VIA THE NORMAL COMPLAINT PROCESS FOR TROUBLESHOOTING WITH THE CUSTOMER. POTENTIAL ROOT CAUSE COULD BE IN THE SAMPLE PREPARATION TECHNIQUE USED OR POSSIBLE THAT THE EXTERNAL CONTROLS PANEL HAD AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720697 NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2 (IVD- EUA) 96 TESTS NXTAG RPP + SARS-COV-2 QLT LUMINEX MOLECULAR DIAGNOSTICS, INC. IK056C-0018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown