BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT MRSA/SA BC

    MDR report key: 21481129 · Received February 27, 2025

    Report

    Report Number
    3004530258-2025-00007
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    January 28, 2025
    Report Date
    May 1, 2025
    Manufacturer
    CEPHEID
    Product Code
    NQX
    PMA / PMN Number
    K130894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CURVES AND RESULTS FOR TEST 1 ON (B)(6) 2025 SHOW NORMAL CURVES AND RESULTS, WITH SPA (STAPHYLOCOCCAL PROTEIN A), MEC (METHICILLIN RESISTANCE GENE), AND SEC (STAPHYLOCOCCAL CHROMOSOMAL CASSETTE) CYCLE THRESHOLDS (CTS) ALL BEING 0. - RETEST 1 ON (B)(6) 2025 HAD NORMAL CURVES, WITH SPA AND MEC CTS BOTH AT 0, BUT SEC CT WAS 31.7. THIS RESULT COULD INDICATE THAT THERE COULD BE A VARIATION IN THE BACTERIAL STRAIN PRESENT IN THE SAMPLE. - RETEST 2 ON (B)(6) 2025 ALSO HAD NORMAL CURVES WITH ALL CTS AT 0. CURVES FOR ALL THREE XPERT TESTS APPAR WITHIN NORMAL LIMITS, STAPHYLOCOCCUS AUREUS POSITIVE WAS DETECTED (MIXED COLONIES) VIA MALDI-TOF (S. AUREUS 2.0). SUSCEPTIBILITY WAS PERFORMED USING MSSA VIA VITEK AND DISK, THERE WAS NO PRODUCT MALFUNCTION SEEN IN ANALYTICL OUTPUTS, GIVEN THREE NEGATIVE RESULTS ON XPERT MRSA/SA BC LOT: 22102, ALL FROM THE SAME BLOOD CULTURE BOTTLE. THE LABORATORY SCIENTIST DID NOT SHARE WHICH RESULTS WERE REPORTED TO THE PHYSICIAN. HEY ONLY WANT A DISCREPANT TECHNICAL REVIEW, AND DID NOT PROVIDE ANY PATIENT RELATED DETAILS TO CEPHEID TECHNICAL SUPPORT. IT WAS HOWEVER CONFIRMED THERE WAS NO PATIENT HARM OR IMPACT. THE ORIGINAL BLOOD CULTURE BOTTLE HAS BEEN RETAINED AND WILL BE SENT TO CPEHEID FOR FURTHER INVESTIGATION (SEQUENCING). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF SEQUENCING. NOTE FOR SECTION H3 DEVICE EVALUATED BY MANUFACTURER - ANSWER IS NO DUE TO THE SINGLE USE OF THE XPERT MRSA/SA BC TEST AND THE UNAVAILABILITY OF THAT PRODUCT LOT TO BE RETURNED TO CEPHEID.

    Additional Manufacturer Narrative · 0

    CUSTOMER PROCESSED ALL SAMPLES PER PACKAGE INSERT WITH NO DEVIATIONS. CURVES AND RESULTS FOR TEST 1 ON 28-JAN-25 SHOW NORMAL CURVES AND RESULTS, WITH SPA (STAPHYLOCOCCAL PROTEIN A), MEC (METHICILLIN RESISTANCE GENE), AND SCC (STAPHYLOCOCCAL CHROMOSOMAL CASSETTE) CYCLE THRESHOLDS (CT'S) ALL BEING 0. RETEST 1 ON 29-JAN-25 HAD NORMAL CURVES, WITH SPA AND MEC CT'S BOTH AT 0, BUT SCC CT WAS 31.7. RETEST 2 ON 29-JAN-25 ALSO HAD NORMAL CURVES WITH ALL CT'S AT 0. CURVES FOR ALL THREE XPERT TESTS APPEAR WITHIN NORMAL LIMITS. THERE WAS NO PRODUCT MALFUNCTION SEEN IN ANALYTICAL OUTPUTS, GIVEN THREE NEGATIVE RESULTS ON XPERT MRSA/SA BC LOT 22102, ALL FROM THE SAME BLOOD CULTURE BOTTLE. NO PATIENT INFORMATION HAS BEEN SHARED BY THE CUSTOMER INCLUDING WHICH RESULTS WERE REPORTED TO THE REQUESTING PHYSICIAN, PATIENT IMPACT OR PATIENT CLINICAL NOTES, CITING PRIVACY CONCERNS. THE CUSTOMER WAS ASKED TO PROVIDE THE SEQUENCING DATA, BUT NONE HAS BEEN PROVIDED TO CEPHEID AS OF NOW. AS OF TODAY'S DATE, (4 APR 2025), DESPITE SEVERAL ATTEMPTS, CEPHEID HAS CONCLUDED THAT THE CUSTOMER HAS BEEN UNWILLING TO PROVIDE A SAMPLE RELATED TO THIS CASE (DESPITE SEVERAL ATTEMPTS) AND THEREFORE COULD NOT PERFORM SEQUENCING IN CEPHEID INTERNAL LABORATORY. ANALYSIS OF THE DATA FROM ALL 3 XPERT MRSA/SA BC LOT 22102 TESTS RESULTS INDICATE THE MOST LIKELY ROOT CAUSE FOR THESE FALSE NEGATIVE RESULTS IS THE PRESENCE OF A VARIANT STRAIN FOR THE STAPHYLOCOCCUS AUREUS. CEPHEID US RECEIVED AND BECAME AWARE OF UPDATED INFORMATION ON 03APR2025. CEPHEID'S PATIENT SAFETY BOARD (PSB) MEMBER MANAGING THIS CASE AND IN CONTACT WITH THE CUSTOMER IS LOCATED IN AUSTRALIA. DUE TO THE TIME ZONE DIFFERENCE BETWEEN AUSTRALIA AND THE US, THE DATE OF NEW INFORMATION REPORTED BY PSB IS DOCUMENTED AS 04APR2025. ALL ANNEX CODES HAVE BEEN UPDATED TO REFLECT THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, CUSTOMER CONTACTED CEPHEID TECHNICAL SUPPORT TO REPORT A CASE OF QUESTIONABLE NEGATIVE RESULTS WITH XPERT MRSA/SA BC. ON (B)(6) 2025, CUSTOMER COLLECTED SAMPLE 1 (BLOOD DRAWN FROM DIRECT VENIPUNCTURE) AND INCUBATED IT AT 13:52 AWST. ON (B)(6) 2025 AT 22:07 AWST, THE AEROBIC BOTTLE FOR THE DETECTION OF AEROBIC BACTERIA FLAGGED POSITIVE AND WAS REMOVED 35 MINUTES LATER. A GRAM STAIN WAS PERFORMED, REVEALING GRAM-POSITIVE COCCI. CULTURE WAS PERFORMED USING BA (BLOOD AGAR), BA-ANAEROBIC, AND CHOC (CHOCOLATE AGAR) PLATES. COLONY VARIATION WAS NOTED BUT ALL CONFIRMED TO BE STAPHYLOCOCCUS AUREUS BY SUBSEQUENT MALDI-TOF (MATRIX-ASSISTED LASER DESORPTION/IONIZATION­ TIME OF FLIGHT) TESTING: S. AUREUS > 2.0 - BEST AND SECOND-BEST MATCHES. SUSCEPTIBILITY TESTING WAS DONE USING MSSA (METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS) BY VITEK AND DISC SUSCEPTIBILITY. ON (B)(6) 2025 AT 22:42:30 AWST, TEST 1 WAS PERFORMED WITH XPERT MRSA/SA BC (METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS/STAPHYLOCOCCUS AUREUS BLOOD CULTURE), LOT: 22102, WITH RESULTS SHOWING: MRSA NEGATIVE AND SA NEGATIVE. THE SAMPLE WAS STORED AT ROOM TEMPERATURE BETWEEN REPEATED TESTS. ON (B)(6) 2025 AT 09:46:50 AWST, RETEST 1 FROM THE BLOOD CULTURE BOTTLE WAS CONDUCTED WITH XPERT MRSA/SA BC LOT: 22102, RESULTING IN MRSA NEGATIVE AND SA NEGATIVE. ANOTHER TEST, RETEST 2, WAS DONE ON THE SAME DAY AT 11:46:30 AWST FROM A COLONY, AND AGAIN THE RESULTS WERE MRSA NEGATIVE AND SA NEGATIVE. THE CUSTOMER PROCESSED ALL SAMPLES PER THE PACKAGE INSERT WITHOUT DEVIATIONS. IT IS UNKNOWN WHICH TEST RESULT HAS BEEN REPORTED TO THE TREATING PHYSICIAN. HOWEVER, NO PATIENT HARM OR IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030916 XPERT MRSA/SA BC XPERT MRSA/SA BLOOD CULTURE NQX CEPHEID 1001456692

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown