BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPERT CT/NG

    MDR report key: 20635932 · Received November 7, 2024

    Report

    Report Number
    3004530258-2024-00016
    Event Type
    Injury
    Date Received
    November 7, 2024
    Date of Event
    October 6, 2024
    Report Date
    January 2, 2025
    Manufacturer
    CEPHEID AB
    Product Code
    MKZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS OF THE RUN FILES REVEALED SLIGHT ABNORMALITIES IN THE PRESSURE CURVE, WHICH MAY HAVE CAUSED THE FALSE POSITIVE RESULT. ADDITIONALLY, A REVIEW OF THE LOT DATA DID NOT INDICATE EITHER A SYSTEMIC OR A LOT MALFUNCTION, SUGGESTING THAT THE ROOT CAUSE WAS RELATED TO THE SAMPLE VISCOSITY OR AN INDIVIDUAL CARTRIDGE EVENT. THIS INCIDENT HAS BEEN EVALUATED AS AN ISOLATED ANOMALY, WITH THE MOST PROBABLE CAUSE IDENTIFIED AS AN INDIVIDUAL CARTRIDGE EVENT OR SAMPLE VISCOSITY ISSUE. THE ANALYSIS INDICATES THAT THERE IS NO SYSTEMIC OR LOT-WIDE MALFUNCTION. NO OTHER ACTION REQUIRED. THERE WAS PATIENT ANXIETY AND DISTRESS AS THIS FALSE POSITIVE RESULT CAUSED MISUNDERSTANDING BETWEEN THE COUPLE. SECTION H6 CODES HAVE BEEN UPDATED TO REFLECT THE OUTCOME OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ON 16-OCT-2024, CUSTOMER REPORTS A DISCREPANT RESULT (FALSE POSITIVE) OBTAINED WITH XPERT CT/NG LOT 35922 (CT= CHLAMYDIA TRACHOMATIS, NG= NEISSERIA GONORRHOEAE) AGAINST THE RESULT OBTAINED USING THE SAME GENEXPERT (GX). ON (B)(6) 2024, VAGINAL SWAB SAMPLE WAS COLLECTED AND PROCESSED AS PER PACKAGE INSERT. THE SAMPLE WAS TESTED STRAIGHT. THE SAMPLE GAVE CT DETECTED; NG NOT DETECTED (CTS VALUES OF CT1 13,7; NG2 13,6; NG4 0,0). CUSTOMER PROVIDED THIS RESULT TO MEDICAL DOCTOR, AND THIS CAUSED ISSUES AT PATIENT LEVEL SINCE THEY WEREN'T EXPECTING A POSITIVE RESULT. AFTER 5 DAYS, WHEN SAMPLE WAS STORED AT 4°C, CUSTOMER WANTED TO RETEST THE SAME SAMPLE WITH GENEXPERT. ON (B)(6) 2024, THE SAME SAMPLE WAS TESTED AND GAVE CT NOT DETECTED; NG NOT DETECTED (CTS VALUES OF CT1 0,0; NG2 0,0; NG4 0,0). DUE TO THIS DISCREPANCY, CUSTOMER PROCEEDED WITH EXTRACTING A NEW VAGINAL SWAB FROM THE SAME PATIENT AND PROCESSED IT AS PER PACKAGE INSERT. ON (B)(6) 2024, THIS NEW SAMPLE WAS TESTED AND GAVE CT NOT DETECTED; NG NOT DETECTED (CTS VALUES OF CT1 0,0; NG2 0,0; NG4 0,0). MOREOVER, WHEN ANALYZING THE CURVES FROM THE FIRST RUN OF THE (B)(6) 2024, CUSTOMER NOTICED THAT THE AMPLIFICATION CURVES HAVE A NEGATIVE SLOPE AND NEVERTHELESS THE SYSTEM GAVE A CT DETECTED RESULT. AS A RESULT, CUSTOMER HAD A LEGAL CLAIM FROM THE PATIENT DUE TO THIS DISCREPANCY. THERE WAS PATIENT ANXIETY AND DISTRESS AS THIS FALSE POSITIVE RESULT CAUSED MISUNDERSTANDING BETWEEN THE COUPLE. ANALYSIS OF THE RUN FILES REVEALED SLIGHT ABNORMALITIES IN THE PRESSURE CURVE, POSSIBLY CAUSING THE FALSE POSITIVE. REVIEW OF THE LOT DATA SHOWED NO SYSTEMIC OR LOT MALFUNCTION, SUGGESTING THE ROOT CAUSE WAS SAMPLE VISCOSITY OR AN INDIVIDUAL CARTRIDGE EVENT. FURTHER INTERNAL INVESTIGATION IS BEING INITIATED.

    Description of Event or Problem · 0

    ON 16-OCT-2024, CUSTOMER REPORTS A DISCREPANT RESULT (FALSE POSITIVE) OBTAINED WITH XPERT CT/NG (CT= CHLAMYDIA TRACHOMATIS, NG= NEISSERIA GONORRHOEAE) AGAINST THE RESULT OBTAINED USING THE SAME GENEXPERT (GX). ON (B)(6) 2024, VAGINAL SWAB SAMPLE WAS COLLECTED AND PROCESSED AS PER PACKAGE INSERT. THE SAMPLE WAS TESTED STRAIGHT. THE SAMPLE GAVE CT DETECTED; NG NOT DETECTED (CTS VALUES OF CT1 13,7; NG2 13,6; NG4 0,0). CUSTOMER PROVIDED THIS RESULT TO MEDICAL DOCTOR, AND THIS CAUSED ISSUES AT PATIENT LEVEL SINCE THEY WEREN'T EXPECTING A POSITIVE RESULT. AFTER 5 DAYS, WHEN SAMPLE WAS STORED AT 4°C, CUSTOMER WANTED TO RETEST THE SAME SAMPLE WITH GENEXPERT. ON (B)(6) 2024, THE SAME SAMPLE WAS TESTED AND GAVE CT NOT DETECTED; NG NOT DETECTED (CTS VALUES OF CT1 0,0; NG2 0,0; NG4 0,0). DUE TO THIS DISCREPANCY, CUSTOMER PROCEEDED WITH EXTRACTING A NEW VAGINAL SWAB FROM THE SAME PATIENT AND PROCESSED IT AS PER PACKAGE INSERT. ON (B)(6) 2024, THIS NEW SAMPLE WAS TESTED AND GAVE CT NOT DETECTED; NG NOT DETECTED (CTS VALUES OF CT1 0,0; NG2 0,0; NG4 0,0). MOREOVER, WHEN ANALYZING THE CURVES FROM THE FIRST RUN OF THE (B)(6) 2024, CUSTOMER NOTICED THAT THE AMPLIFICATION CURVES HAVE A NEGATIVE SLOPE AND NEVERTHELESS THE SYSTEM GAVE A CT DETECTED RESULT. AS A RESULT, CUSTOMER HAD A LEGAL CLAIM FROM THE PATIENT DUE TO THIS DISCREPANCY. THERE WAS PATIENT ANXIETY AND DISTRESS AS THIS FALSE POSITIVE RESULT CAUSED MISUNDERSTANDING BETWEEN THE COUPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815863 XPERT CT/NG XPERT CT/NG MKZ CEPHEID AB 1001445766

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other