MAUDE Adverse Event Report: CEPHEID CEPHEID XPERT MTB/RIF; XPERT MTB/RIF ASSAY

Catalog Number	GXMTB/RIF-US-10
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Us customer contacted cepheid on (b)(6) 2024 to report a questionable negative result using xpert mtb/rif.Collection 1: on (b)(6) 2024, an induced sputum sample was collected.Sputum sediment was tested per pi on xpert mtb/rif on (b)(6) 2024, which resulted in mtb not detected.This was reported to the physician.Afb smear was positive.M.Tuberculosis identified from culture.Collection 2: on (b)(6) 2024, an induced sputum sample was collected.Sputum sediment was tested per pi on xpert mtb/rif on (b)(6) 2024, which resulted in mtb not detected.This was reported to the physician.Afb smear was negative.M.Tuberculosis identified from culture.Collection 3: on (b)(6) 2024, an induced sputum sample was collected.Sputum sediment was tested per pi on xpert mtb/rif on (b)(6) 2024, which resulted in mtb not detected.This was reported to the physician.Afb smear was negative.M.Tuberculosis identified from culture.Collection 4: on (b)(6) 2024 an induced sputum sample was collected.Sputum sediment was tested per pi on xpert mtb/rif on (b)(6) 2024, which resulted in mtb not detected.This was reported to the physician.Afb smear was negative.M.Tuberculosis was not identified from culture.Collection 5: on (b)(6) 2024 an induced sputum sample was collected.Sputum sediment was tested per pi on xpert mtb/rif on (b)(6) 2024, which resulted in mtb not detected.This was reported to the physician.Afb smear was negative.M.Tuberculosis was not identified from culture.Customer followed kent and kubica method for decontamination and concentration.Nalc/naoh method was used at a final concentration of 1.5% of naoh.Samples were refrigerated prior to testing.Customer does not know when treatment was started.Possibly after mtb culture report, samples at some point collected after patient started treatment and is off label use.Customer didn't perform any other tests on the samples besides afb and culture.In section b1, b2 and h1, we have catagorized this incident as a serious injury and adverse event, however cepheid has not yet confirmed that there was an adverse event or malfunction.Currently, there is no confirmation of malfunction and no report of serious injury.However, the investigation is ongoing.Additional information regarding likely root cause will be provided in a follow up report once the investigation has been completed.
Event or Problem Description
Us customer contacted cepheid on (b)(6) 2024 to report a questionable negative result using xpert mtb/rif.Collection 1: on (b)(6) 2024, an induced sputum sample was collected.Sputum sediment was tested per pi on xpert mtb/rif on (b)(6) 2024, which resulted in mtb not detected.This was reported to the physician.Afb smear was positive.M.Tuberculosis identified from culture.Collection 2: on (b)(6) 2024, an induced sputum sample was collected.Sputum sediment was tested per pi on xpert mtb/rif on (b)(6) 2024, which resulted in mtb not detected.This was reported to the physician.Afb smear was negative.M.Tuberculosis identified from culture.Collection 3: on (b)(6) 2024, an induced sputum sample was collected.Sputum sediment was tested per pi on xpert mtb/rif on (b)(6) 2024, which resulted in mtb not detected.This was reported to the physician.Afb smear was negative.M.Tuberculosis identified from culture.Collection 4: on (b)(6) 2024 an induced sputum sample was collected.Sputum sediment was tested per pi on xpert mtb/rif on (b)(6) 2024, which resulted in mtb not detected.This was reported to the physician.Afb smear was negative.M.Tuberculosis was not identified from culture.Collection 5: on (b)(6) 2024 an induced sputum sample was collected.Sputum sediment was tested per pi on xpert mtb/rif on (b)(6) 2024, which resulted in mtb not detected.This was reported to the physician.Afb smear was negative.M.Tuberculosis was not identified from culture.Customer followed kent and kubica method for decontamination and concentration.Nalc/naoh method was used at a final concentration of 1.5% of naoh.Samples were refrigerated prior to testing.Customer does not know when treatment was started.Possibly after mtb culture report, samples at some point collected after patient started treatment and is off label use.Customer didn't perform any other tests on the samples besides afb and culture.
Additional Manufacturer Narrative
The following patient information was provided from tb control to cepheid.The patient is a 51-year-old male, born in vietnam.Patient has chronic hbv and is on entecavir.Patient also has history of diabetes mellitus and hyperlipidemia.The patient experienced exposure to his mother who was infectious with tb disease.Cxr had very subtle abnormalities.Positive serum quantiferon gold.3 sputa collected in may and all mtb/rif negative, all culture positive, first was 1+ smear.Tb therapy was not started until (b)(6) 2024, when first may specimen was culture positive.Per tb control, this likely resulted in exposure of the community to infectious tb with possible transmission.The patient reported to be symptomatic and per tb control, it seems unlikely, as far as they can tell, that suffered morbidity due to the several-week delay in the initiation of tb chemotherapy for active pulmonary tb disease.The clinician is not available for discussion and the clinical information provided was by the program doctor at la county tb control.In attempt to perform further analysis, we were unable to retrieve the files from the customer.To date, review of cepheid's complaint data and internal control data for release of this lot show no indication of lot or systemic malfunction.The root cause in this case is inconclusive.Currently, there is no confirmation of malfunction and no report of serious injury.Additional follow-up: at cepheid's request, the customer tested two isolates from this patient, and both were mtb detected, rif resistance not detected.This suggests that the false negative result was not due to something intrinsic to the strain of tb such as sequence diversity.Section h6 investigation findings and investigations conclusions, health effect clinical and health effect impact codes have been updated to reflect the outcome of the investigation.

• Brand Name: CEPHEID XPERT MTB/RIF
• Common Device Name: XPERT MTB/RIF ASSAY
• 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: 20045223
• Report Number: 3004530258-2024-00013
• Device Sequence Number: 7955632
• Product Code: PEU
• UDI-Device Identifier: 07332940000912
• UDI-Public: 07332940000912
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: DEN130032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2025
• Device Catalogue Number: GXMTB/RIF-US-10
• Device Lot Number: 1001416984
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown