BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16718794 · Received April 11, 2023

    Report

    Report Number
    3002777243-2023-00004
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    December 2, 2022
    Report Date
    April 11, 2023
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS, INC.
    Product Code
    QLT
    PMA / PMN Number
    EUA210031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 CUSTOMER, TRICORE REFERENCE LABORATORIES REPORTED THAT THEY WERE UNABLE TO DETECT HUMAN METAPNEUMOVIRUS (HMPV) WHEN PERFORMING QC TESTING OF LOT IK056C-0020 OF THE NXTAG RPP+SARS-COV-2 ASSAY (PN: I056C0468). HMPV SIGNAL WAS REPORTED TO BE JUST BELOW THE THRESHOLD, I.E. APPROXIMATELY 80 MDD. UPON REPEAT FROM A NEW EXTRACTION, WITH THE SAME KIT BOX, HMPV PASSED BUT WITH SIGNALS JUST ABOVE THE THRESHOLD. CUSTOMER ALSO NOTED THAT THE FOIL SEAL APPEARED TO BE MISALIGNED ON THE KIT THAT THEY TESTED. TECHNICAL SUPPORT HAD CUSTOMER INSPECT ADDITIONAL KITS OF THE COMPLAINT LOT AND OF THE 3 KITS INSPECTED, CUSTOMER DID NOT NOTE ANY OTHER MISALIGNMENT OF THE FOIL SEAL. TS INSTRUCTED CUSTOMER TO REPEAT THE SAMPLES USING A SECOND KIT (WITH NO FOIL MISALIGNMENT). ON (B)(6) 2022, CUSTOMER REPORTED THAT THE REPEAT RUN WITH A NEW KIT BOX WAS SUCCESSFUL, HMPV WAS DETECTED. HOWEVER, CUSTOMER WAS UNABLE TO SEND RUN DATA AND NO FURTHER DATA REVIEW COULD BE PERFORMED. ON (B)(6) 2023, TS REQUEST THE RETURN OF THE KIT WITH THE MISALIGNED FOIL SEAL FOR INTERNAL INVESTIGATION. STRIPS WERE RECEIVED ON (B)(6) 2023 AND INVESTIGATION WAS INITIATED ON TEAM TASK, T-00027729. LUMINEX QUALITY CONTROL REPEATED THE RUN WITH A NEW KIT OF THE COMPLAINT LOT, IK056C-0020 AND REPORTED THAT ALL EXPECTED CALLS WERE MADE. THE ORIGINAL QC RELEASE TESTING DATA FOR THE ASSOCIATED PRODUCT WAS ASSESSED AND IT WAS NOTED TO BE WITHIN THE REQUIRED QC RELEASE SPECIFICATIONS FOR ALL TARGETS, INCLUDING HMPV WHICH WAS AT 128 MDD. LEFTOVER STRIPS FROM THE COMPLAINT KIT WERE RETURNED UNDER RMA 20744. UPON TESTING AT LMD, RMA MATERIAL ALSO GENERATED FUNCTIONAL DATA WELL WITHIN THE REQUIRED QC RELEASE SPECIFICATIONS (AT 167, 177, AND 145 MDD). IN REFERENCE TO THE FOIL/BLACK ADHESIVE INTER-SEAL MISALIGNMENT ON ONE KIT PLATE, QC CONFIRMED THE MISALIGNMENT OF THE SEALS CAN MAKE IT HARDER TO PIPETTE SAMPLES INTO THE PLATES. HOWEVER, THIS MISALIGNMENT DID NOT SEEM TO HAVE IMPACTED THE FUNCTIONAL DATA AS THE RMA MATERIAL FUNCTIONAL TESTING WAS PERFORMED ON THE VERY SAME MISALIGNED STRIPS THAT WERE RETURNED FOR INVESTIGATION. CONSUMABLE REVIEW: 12 MONTH HISTORICAL REVIEW ON LOT IK056C-0020 DID NOT REVEAL ANY RELATED COMPLAINTS THAT WERE CONFIRMED. DEVICE REVIEW: MAGPIX SN: (B)(4). A 12 MONTH HISTORICAL REVIEW SHOWED 4 CASES THAT HAD BEEN REPORTED ON THIS SERIAL NUMBER: CASE (B)(4): COMPLAINT WAS ON DELTA CALIBRATION TEMPERATURE SHOWING OUT OF RANGE RESULTING IN FAILED CALIBRATIONS. THE FIELD SERVICE ENGINEER ON SITE COULD NOT REPEAT THIS ISSUE AND THEREFORE WAS UNCONFIRMED. THIS ISSUE DID NOT REOCCUR AND IS UNRELATED TO THE CURRENT ISSUE. CASE (B)(4): THIS COMPLAINT WAS ON LOW BEAD COUNTS SEEN WHEN RUNNING THE NXTAG RPP ASSAY ON THE INSTRUMENT. A SIMILAR ISSUE WAS OCCURRING SIMULTANEOUSLY ON THE OTHER MAGPIX INSTRUMENT AT THE CUSTOMER SITE. USE OF THE CLEANING BLEACH ON THE HARDWARE WAS DETERMINED TO BE A PROBLEM AND FSE REPAIRED ACCORDINGLY. THIS IS UNRELATED TO THE CURRENT ISSUE. CASE (B)(4): THIS IS A HARDWARE RELATED COMPLAINT WHERE BUBBLES WERE NOTED IN THE SAMPLE LINE. THE ISSUE FIXED ITSELF PER THE CUSTOMER AND DID NOT REOCCUR. THIS IS UNRELATED TO THE CURRENT ISSUE. CASE (B)(4): CUSTOMER COMPLAINED ABOUT AN UNDETECTED GENE BUT DETECTION ON SUBTYPES ON THE NXTAG RPP+SARS-COV-2 ASSAY LOT IK056C-0014 AND IK056C-0006. HOWEVER, THIS ISSUE COULD NOT BE CONFIRMED BECAUSE OF THE LIMITED INFORMATION PROVIDED BY THE CUSTOMER. INTERNAL ASSESSMENT REVEALED THAT THE CALL WOULD BE CONSIDERED VALID AS A NEGATIVE GENE AND POSITIVE SUBTYPE CAN OCCUR. 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 ON A QC RUN PERFORMED BY THE CUSTOMER. 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 FOR A SLIGHTLY BELOW THRESHOLD HMPV RESULT, LIMITED TO ONLY 1 RUN COULD BE IN THE SAMPLE PREPARATION TECHNIQUE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720704 NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2 (IVD-EUA) 96 TESTS NXTAG RPP + SARS-COV-2 QLT LUMINEX MOLECULAR DIAGNOSTICS, INC. IK056C-0020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown