BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT MRSA/SA BC (CE-IVD)

    MDR report key: 24298121 · Received February 9, 2026

    Report

    Report Number
    3004530258-2026-00002
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 10, 2026
    Report Date
    February 9, 2026
    Manufacturer
    CEPHEID
    Product Code
    NQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A POSITIVE BLOOD CULTURE WAS TESTED ACCORDING TO THE INSTRUCTIONS FOR USE WITH EXPERT MRSA SA BC AND GAVE AS A RESULT "SA NOT DETECTED". AS PART OF THE LAB'S SOP THE SAME SAMPLE WAS TESTED BY MALDI AND GAVE AS A RESULT "STAPHYLOCOCCUS AUREUS". THE SAMPLE WAS RETESTED WITH EXPERT MRSA SA BC AND GAVE THE SAME "SA NOT DETECTED" RESULT. NEXT DAY, CULTURE ISOLATED A MSSA THAT WAS TESTED (OFF-LABEL) WITH EXPERT MRSA SA BC AND GAVE A "SA NOT DETECTED" RESULT. ANALYSIS OF THE CURVES SHOWED NO ABNORMALITIES. ALL THE 3 TARGETS WERE CONSISTENTLY ASSOCIATED WITH CT=0. THE LIKELY ROOT CAUSE IS A SPA VARIANT MSSA. NO IMPACT ON PATIENT AS THE MALDI GAVE THE RIGHT RESULT (SA). THE ISOLATE WAS SEQUENCED BY THE FRENCH NATIONAL REFERENCE LAB. ON 05-FEB-2026, CEPHEID RECEIVED THE FASTA FILE AND UPON ANALYSIS, REVEALED A HUGE DELETION IN THE SPA GENE, CONFIRMING THE LIKELY ROOT CAUSE (SPA VARIANT). DETERMINATION : FALSE NEGATIVE LIKELY ROOT CAUSE : MUTATION/GENETIC DRIFT THE DETERMINATION OF THIS CASE IS A FALSE NEGATIVE DUE TO MUTATION/GENETIC DRIFT. CEPHEID CONSIDERS THIS ROOT CAUSE AS A MALFUNCTION; THEREFORE THIS CASE IS DEEMED REPORTABLE. NOTE FOR SECTION H3 DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF THE XPERT MRSA/SA BC TEST AND THE UNAVAILABILITY OF THAT PRODUCT LOT TO BE RETURNED TO CEPHEID.

    Description of Event or Problem · 0

    ON 13 JAN 2026, A DOCTOR CONTACTED TECHNICAL SUPPORT TO REPORT A DISCREPANT RESULT ON THE XPERT MRSA/SA BC LOT 23201/1001505983 [METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS / STAPHYLOCOCCUS AUREUS BLOOD CULTURE]. THE PATIENT IS A 94 YEAR OLD INDIVIDUAL WITH A MEDICAL HISTORY OF ATRIAL FIBRILLATION AND A PACEMAKER. THE PATIENT WAS NOT IMMUNOCOMPROMISED AND HAD NO HISTORY OF DIABETES OR CANCER. A PERIPHERAL VENOUS CATHETER AND A PACEMAKER WERE IN PLACE. NO ANTIBIOTICS HAD BEEN ADMINISTERED BEFORE BLOOD COLLECTION, AND THE PATIENT'S GENERAL CONDITION WAS STABLE. A BLOOD CULTURE SAMPLE WAS COLLECTED ON (B)(6) 2026 USING A BACTEC LYTIC/ANAEROBIC BOTTLE. THE ANAEROBIC BOTTLE FLAGGED POSITIVE ON(B)(6) 2026 AT 5:26 PM. GRAM STAIN WAS PERFORMED AND SHOWED GRAM POSITIVE COCCI IN CLUSTERS. CULTURE WAS PERFORMED ON COLUMBIA BLOOD AGAR AND SHOWED ONLY STAPHYLOCOCCUS AUREUS COLONIES. SUSCEPTIBILITY TESTING WAS PERFORMED ON MUELLER HINTON AGAR USING A SASM (STAPHYLOCOCCUS AUREUS SUSCEPTIBLE TO METHICILLIN) PANEL, AND THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE FIRST XPERT MRSA/SA BC TEST WAS PERFORMED ON (B)(6) 2026 USING TEST METHOD SPECIFIED IN THE INSTRUCTIONS FOR USE AND LOT 23201, AND THE RESULT WAS: MRSA NEG AND SA NEG. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. A MALDI TOF (MATRIX ASSISTED LASER DESORPTION IONIZATION-TIME OF FLIGHT) IDENTIFICATION WAS ALSO PERFORMED THE SAME DAY AND GAVE A POSITIVE RESULT FOR S. AUREUS, AND THIS IS THE ONLY RESULT TRANSMITTED TO THE PHYSICIAN. TO OBTAIN INFORMATION REGARDING METHICILLIN RESISTANCE, REPEAT TESTING ON THE XPERT MRSA/SA BC ASSAY WAS CONDUCTED ON (B)(6) 2026 USING THE SAME LOT NUMBER, AND THE TEST GAVE THIS RESULTS: MRSA NEG AND SA NEG. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE BLOOD CULTURE MATERIAL WAS STORED AT AMBIENT TEMPERATURE BETWEEN TESTS. ON (B)(6) 2026, A SECOND SAMPLE, A BACTERIAL ISOLATE WAS COLLECTED. THEN IT WAS TESTED USING A BACTERIAL ISOLATE TESTING PROTOCOL PROVIDED FROM CEPHEID DOCTOR TO THE CUSTOMER FOR TROUBLESHOOTING PURPOSES. THIS TESTING WAS PERFORMED ON (B)(6) 2026 USING XPERT MRSA/SA BC LOT 23201, AND THE RESULT WAS MRSA NEG AND SA NEG. THE ISOLATE WAS IDENTIFIED AS METHICILLIN SUSCEPTIBLE S. AUREUS. THERE WAS NO HARM TO THE PATIENT, NO CLINICAL IMPACT, AND NO ADVERSE OUTCOME RELATED TO THE DISCREPANCY. THE PATIENT WAS DISCHARGED AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361994 XPERT MRSA/SA BC (CE-IVD) XPERT MRSA/SA BLOOD CULTURE NQX CEPHEID 1001505983

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Unknown