MAUDE Adverse Event Report: CEPHEID XPERT XPRESS COV-2/FLU/RSV PLUS

Catalog Number	XPRS4PLEX-10
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient had 2 nasopharyngeal (np) swabs collected and placed in 3ml utm on (b)(6) 2025.On the same day, one swab was tested on xpert xpress cov-2/flu/rsv plus, lot 68119, and resulted as sars-cov-2 negative, flu a negative, flu b negative, and rsv negative.This result was reported to the physician.Due to the xpert result giving negative on all analytes and clinician suspected patient had flu, the other np swab was tested the same day on quidel's sofia flua/flub rapid antigen test which resulted as flu a negative, flu b positive.This result was reported to the physician.Data for xpert xpress cov-2/flu/rsv plus shows no indication of malfunction with flu b ct of 0, indicating there's no target.Internal data shows no issues with the lot or any complaint trends with this lot.The customer stated with other xpert lots, flu b is being detected, which states flu b is circulating.Cepheid advised at the possibility of the sofia test giving inaccurate results, but customer doesn't have a case opened with quidel.Patient is a 1.5-year-old with no underlying conditions and presented at the clinic with a cough and flu-like symptoms.After the results from xpert and (b)(6).The patient was given the diagnosis for having flu, but no treatment was provided.Advised parents to monitor patient until recovery.Customer confirmed there was no patient harm or impact due to the differing results.Customer no longer has the np swabs as they are discarded after testing, hence no other confirmatory testing can be performed.Determination of the case is inconclusive as well as the root cause.
Event or Problem Description
Us customer contacted cepheid to report a questionable negative result for flu b using the xpert xpress cov-2/flu/rsv plus assay.Patient was tested using xpert xpress cov-2/flu/rsv plus lot 68119 which resulted in sars-cov-2 negative, flu a negative, flu b negative, rsv negative.Sample was processed per ifu.This result was reported to the physician.Two nasopharyngeal swabs were collected for this patient at the same time.When results of xpert xpress cov-2/flu/rsv plus ivd were reported as negative for all targets, the customer questioned the flu results since they highly suspected the patient had the flu as the patient presented with a cough and flu-like symptoms.They used the second swab to test with their sofia quidel rapid flu a/flu b test.Samples were stored at room temperature prior to testing.Sofia quidel rapid flu a/flu b test resulted in flu a negative, flu b positive.This result was reported to the physician.The lot number for sofia quidel is unknown.There were no known underlying conditions and no known impact on the patient due to the discrepancy.

• Brand Name: XPERT XPRESS COV-2/FLU/RSV PLUS
• Common Device Name: XPERT XPRESS COV-2/FLU/RSV PLUS
• Manufacturer (Section D): CEPHEID; 904 e caribbean dr; sunnyvale CA 94089
• Manufacturer (Section G): CEPHEID; 904 e caribbean dr; sunnyvale CA 94089
• Manufacturer Contact: somesh lalithraj ; 904 e caribbean dr; sunnyvale, CA 94089 ; 4085488951
• MDR Report Key: 23720161
• Report Number: 3004530258-2025-00040
• Device Sequence Number: 16039843
• Product Code: QOF
• UDI-Device Identifier: 07332940008604
• UDI-Public: 07332940008604
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K242071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: XPRS4PLEX-10
• Device Lot Number: 1001491980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 18 MO
• Patient Sex: Unknown