XPERT MRSA NXG
Report
- Report Number
- 3004530258-2025-00009
- Event Type
- Death
- Date Received
- March 13, 2025
- Date of Event
- January 26, 2025
- Report Date
- April 11, 2025
- Manufacturer
- CEPHEID
- Product Code
- NQX
- UDI-DI
- 07332940001711
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER IN B5, B6 AND H11 IS IN RESPONSE TO FDA QUESTIONS AS WELL AS CLARIFICATION ON TESTS PERFORMED. THE CORRECTION APPLIES TO SECTION B5 IN ADDING THE BIOFIRE TEST WHICH WAS INADVERTENTLY LEFT OUT OF THE B5 SECTION IN THE INITIAL REPORT. THE CORRECTION ALSO APPLIES TO SECTION B6 TO CORRECT SAMPLE NUMBER AND UNKNOWN DATE. AS REPORTED TO CEPHEID BY CUSTOMER, THE HOSPITAL WAS FOLLOWING THEIR OWN PROTOCOLS FOR ANTIBIOTIC STEWARDSHIP. CEPHEID DOES NOT KNOW WHAT GUIDED THE ANTIBIOTIC THERAPY. HOWEVER, BASED UPON CEPHEID MEDICAL AFFAIRS STAFF'S EXPERIENCE, WE BELIEVE THAT IT IS LIKELY THAT THE BIOFIRE BCID RESULTS PERFORMED ON A POSITIVE BLOOD CULTURE (SAMPLE 2) WHICH RESULTED NEGATIVE FOR MRSA PROMPTED DECISION ON WHICH ANTIBIOTIC TO USE. ON THE OTHER HAND, THE XPERT MRSA NXG TEST IS NOT INTENDED TO DIAGNOSE, GUIDE, OR MONITOR TREATMENT FOR MRSA INFECTIONS, OR PROVIDE RESULTS OF SUSCEPTIBILITY TO METHICILLIN. IN THIS SPECIFIC CASE, THE USE OF XPERT MRSA NXG TEST RESULTS FROM SAMPLE 1 (NASAL SWAB) WHICH RESULTED NEGATIVE FOR MRSA TO GUIDE ANTIBIOTIC TREATMENT WOULD BE A USER ERROR. THE PATIENT WAS ADMITTED ON (B)(6) IN A STATE OF SHOCK AFTER CARDIOPULMONARY RESUSCITATION DUE TO PULSELESSNESS, WITH ACTIVE SUPPORT FROM VASOACTIVE AMINES. AGGRESSIVE RESUSCITATION COMBINING VASOACTIVE AMINES AND DIALYSIS LED TO TEMPORARY IMPROVEMENT, WHICH HAD TO BE INTERRUPTED DUE TO CARDIAC ARRESTS OCCURRING ON (B)(6), LEADING TO THE FAMILY DECISION TO WITHDRAW THERAPEUTIC INTERVENTION. THE ETIOLOGY OF THE INITIAL SHOCK IS UNKNOWN. CEPHEID MEDICAL AFFAIRS BELIEVE THAT THE AVAILABLE ANAMNESIS ELEMENTS SUGGEST A SEVERE CONDITION AT ADMISSION WITH A HIGHLY CRITICAL SHORT-TERM PROGNOSIS, OCCURRING IN A CONTEXT WITH RISK FACTORS FOR MORTALITY. THE DATE OF DEATH OF THE PATIENT WAS (B)(6) 2025. THE CUSTOMER DOES NOT HAVE ACCESS TO THE PATIENT'S OFFICIAL DEATH CERTIFICATE. ROOT CAUSE OF THE FALSE NEGATIVE MRSA RESULT WITH XPERT MRSA MXG: THE ISOLATED MRSA FROM PATIENT'S NASAL SWAB HAS BEEN SENT TO CEPHEID FOR ANALYSIS. SEQUENCING ANALYSIS OF THE REGION TARGETED BY OUR SCC PRIMERS, THE JUNCTION REGION BETWEEN SCCMEC AND THE S. AUREUS CHROMOSOME, REVEALED THE PRESENCE OF A LARGE INSERTED SEQUENCE THAT SEPARATED THE FORWARD FROM THE REVERSE PRIMER, THUS PREVENTING AMPLIFICATION OF THE SCC TARGET AND THE MRSA DETECTED CALLOUT. ANNEX CODES HAVE BEEN UPDATED TO REFLECT THE COMPLETION OF THE INVESTIGATION.
THE CASE WAS FURTHER REVIEWED, AND THE LAB MANAGER WAS CONTACTED BY PSB. THE LAB MANAGER DID NOT HAVE ANY INFORMATION ABOUT HOW THE FALSE NEGATIVE RESULT AFFECTED THE PATIENT BUT INFORMED US THAT THE PATIENT IS NOW DECEASED. THE LAB MANAGER COMMUNICATED THAT THE BIOFIRE TEST WAS ALSO NEGATIVE FOR MRSA, ALTHOUGH AST AND PBP2A WERE POSITIVE. THE LAB MANAGER REFERRED CEPHEID TO THE MEDICAL DIRECTOR FOR MORE INFORMATION. THE MEDICAL DIRECTOR STATED THAT ONLY ONE DOSE OF VANCOMYCIN WAS GIVEN TO THE PATIENT PRIOR TO THE XPERT MRSA NXG RESULT. VANCOMYCIN THERAPY WAS STOPPED IN WHICH CASE APPROPRIATE THERAPY WAS DISCONTINUED. THE PATIENT WAS SWITCHED TO EITHER NAFCILLIN OR CEFAZOLIN (MEDICAL DIRECTOR COULD NOT SPECIFY WHICH) FOLLOWING THE XPERT MRSA NXG AND BIOFIRE BCID RESULTS. THE MEDICAL DIRECTOR DID NOT PROVIDE THE EXACT DATE THE BIOFIRE TEST WAS PERFORMED. THE INTENDED USE OF XPERT MRSA NXG IS TO DETECT THE PRESENCE OF MRSA DNA IN PATIENTS AT RISK FOR MRSA COLONIZATION, SO IT IS UNLIKELY TO HAVE GUIDED THE ANTIBIOTIC THERAPY. ROOT CAUSE: THE RESULTS ALL POINT TO A POSSIBLE MUTATION IN THE REGION TARGETED BY THE SCC REVERSE PRIMERS. PER REPORT, THE PATIENT PASSED AWAY. THE CHRONOLOGY OF EVENTS, WITH XPERT MRSA NXG TEST ON (B)(6) 2025, BLOOD DRAW ON (B)(6) 2025, SO CULTURE RESULTS AND LIKELY BIOFIRE BCID TEST ON (B)(6) 2025 SUGGEST THE ANTIBIOTIC THERAPY WOULD HAVE BEEN CORRECTED WITHIN A FEW HOURS. AT THIS POINT, THE INVESTIGATION IS STILL ONGOING. AT THIS TIME, PATIENT HARM HAS BEEN REPORTED, HOWEVER MORE INFORMATION NEEDS TO BE OBTAINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS RECEIVED. INTENDED USE PER IFU: THE XPERT MRSA NXG TEST, PERFORMED ON THE GENEXPERT® INSTRUMENT SYSTEM, IS A QUALITATIVE IN VITRO DIAGNOSTIC TEST INTENDED FOR THE DETECTION OF METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) DNA DIRECTLY FROM NASAL SWABS IN PATIENTS AT RISK FOR NASAL COLONIZATION. THE TEST UTILIZES AUTOMATED REAL-TIME POLYMERASE CHAIN REACTION (PCR) FOR THE AMPLIFICATION OF MRSA-SPECIFIC DNA TARGETS AND FLUOROGENIC TARGET-SPECIFIC HYBRIDIZATION PROBES FOR THE REAL-TIME DETECTION OF THE AMPLIFIED DNA. THE XPERT MRSA NXG TEST IS INTENDED TO AID IN THE PREVENTION AND CONTROL OF MRSA INFECTIONS IN HEALTHCARE SETTINGS. THE XPERT MRSA NXG TEST IS NOT INTENDED TO DIAGNOSE, GUIDE, OR MONITOR TREATMENT FOR MRSA INFECTIONS, OR PROVIDE RESULTS OF SUSCEPTIBILITY TO METHICILLIN. A NEGATIVE RESULT DOES NOT PRECLUDE MRSA NASAL COLONIZATION. CONCOMITANT CULTURES ARE NECESSARY TO RECOVER ORGANISMS FOR EPIDEMIOLOGICAL TYPING OR FOR FURTHER SUSCEPTIBILITY TESTING. NOTE FOR SECTION H3 DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF THE XPERT MRSA NXG TEST AND THE UNAVAILABILITY OF THAT PRODUCT LOT TO BE RETURNED TO CEPHEID.
US CUSTOMER CONTACTED CEPHEID TO DISCUSS DISCREPANT RESULTS FOR ONE PATIENT USING MRSA NXG FOR THE MRSA ANALYTE. ON (B)(6) 2025, PATIENT WAS ADMITTED IN A STATE OF SHOCK. ON THE SAME DAY, A NASAL SWAB (SAMPLE 1) WAS COLLECTED ON LABEL USING THE COPAN ESWAB COLLECTION DEVICE AND PROCESSED PER THE IFU. SAMPLE WAS RUN ON (B)(6) 2025 ON XPERT MRSA NXG RESULTED IN MRSA NOT DETECTED. THIS RESULT WAS REPORTED TO THE PHYSICIAN. A SEPARATE BLOOD CULTURE SAMPLE (SAMPLE 2) WAS COLLECTED FROM THE PATIENT ON (B)(6) 2025. THE DIRECT BLOOD SAMPLE WAS PLATED AND THE ISOLATE GROWN WAS IDENTIFIED AS MRSA. THIS RESULT PROMPTED THE CUSTOMER TO PLATE THE NASAL ESWAB SAMPLE 1 ON BAP, CHOC, AND MACCONKEY PLATES. AN ORGANISM GREW AND WAS ISOLATED AND IT WAS IDENTIFIED AS MRSA BY VITEK 2 SUSCEPTIBILITY TESTING, WHICH SHOWED AMOXICILLIN, AMPICILLIN, OXACILLIN, CEFAZOLIN, CIPROFLOXACIN, AND LEVOFLOXACIN RESISTANCE. THE CUSTOMER REPORTED PBP2A TESTING WAS ALSO PERFORMED ON SPECIMEN WHICH RESULTED AS POSITIVE. DATE OF RESULTS UNKNOWN. ON (B)(6) 2025, SAMPLE 2 WAS RAN ON BIOFIRE BCID WHICH RESULTED IN S. AUREUS, NEGATIVE FOR MRSA. THE PATIENT RECEIVED A SINGLE DOSE OF VANCOMYCIN ON (B)(6) 2025. IT WAS STOPPED ACCORDING TO THE HOSPITAL PROTOCOLS FOR ANTIBIOTIC STEWARDSHIP AND WAS NOT RESTARTED. CEPHEID DOES NOT KNOW WHAT GUIDED THE ANTIBIOTIC THERAPY. THE FOLLOWING ANTIBIOTICS WERE ADMINISTERED: PIPERACILLIN/TAZOBACTAM, CLINDAMYCIN, CEFTRIAXONE, AZITHROMYCIN, CEFAZOLIN. THE PATIENT PASSED AWAY ON (B)(6) 2025.
US CUSTOMER CONTACTED CEPHEID TO DISCUSS DISCREPANT RESULTS FOR ONE PATIENT USING MRSA NXG FOR THE MRSA ANALYTE. ON (B)(6) 2025, A NASAL SWAB WAS COLLECTED ON LABEL USING THE COPAN ESWAB COLLECTION DEVICE AND PROCESSED PER THE IFU AND RUN ON XPERT MRSA NXG RESULTED IN MRSA NOT DETECTED. THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS PROCESSED PER THE IFU. THE SAMPLE WAS STORED REFRIGERATED PRIOR TO TESTING. THE CUSTOMER UTILIZED THE TEST TO SCREEN PATIENT FOR MRSA COLONIZATION. A SEPARATE BLOOD CULTURE SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2025. THE DIRECT BLOOD SAMPLE WAS PLATED AND THE ISOLATE GROWN WAS IDENTIFIED AS MRSA. THIS RESULT PROMPTED THE CUSTOMER TO PLATE THE NASAL ESWAB SAMPLE 1 ON BAP, CHOC, AND MACCONKEY PLATES. AN ORGANISM GREW AND WAS ISOLATED AND IT WAS IDENTIFIED AS MRSA BY VITEK 2 SUSCEPTIBILITY TESTING, WHICH SHOWED AMOXICILLIN, AMPICILLIN, OXACILLIN, CEFAZOLIN, CIPROFLOXACIN, AND LEVOFLOXACIN RESISTANCE. THE CUSTOMER REPORTED PBP2A TESTING WAS ALSO PERFORMED ON SPECIMEN WHICH RESULTED AS POSITIVE. THE CUSTOMER DID NOT REPORT ANY KNOWN DEATH, INJURY OR DETERIORATION IN HEALTH RELATED TO THE DISCREPANCY AT THE TIME OF THE INITIAL CALL WITH CEPHEID TECHNICAL SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1495555 | XPERT MRSA NXG | XPERT MRSA NXG | NQX | CEPHEID | 1001462603 | 07332940001711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Death |