MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ ENTERIC BACTERIAL PANEL; GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM

Catalog Number	442963
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of bd max¿ bacterial panel, a false negative salmonella patient result was obtained.The bd max reported a negative result for salmonella spp.Twice, although salmonella grew in culture.Agglutination identified serogroup d, and further diagnostic testing confirmed the isolate as salmonella enteritidis.There was no report of patient impact.This is report 2 of 2.
Additional Manufacturer Narrative
D.2.Additional medical device types: pch, pci.E.1.Initial reporter phone #: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: introduction: the complaint investigation for discrepant results with the bd max¿ enteric bacterial panel kit (ref.(b)(4)) lot 5262914 was performed by the review of manufacturing records, retain material testing, review of customer¿s data and by the complaint¿s history review.Customer reported a single sample that tested negative twice for the salmonella spp.(salm) target using the bd max¿ enteric bacterial panel, whereas the customer reported positive stool culture results identifying salmonella serogroup d.Batch history review: the review of quality control records of bd max¿ enteric bacterial panel assay lot 5262914 revealed no anomalies that could explain the customer¿s discrepant results.Investigational testing: the retain material of bd max¿ enteric bacterial panel from lot 5262914 was tested and the results were as expected.Customer provided run files for runs #19 and #22, along with the database from bd max¿ instrument (b)(6), for one sample (#370) suspected of a false-negative result for the salmonella target (run 19/position b10; run 22/position b5).The customer reported obtaining a salmonella spp positive result for this sample in culture, during evaluation testing of the bd max¿ system, when patient samples were tested in parallel with routine stool culture.Manual pcr curve adjudication revealed late and low amplification in the vic channel (salmonella target) for the initial test, but the signal did not reach the threshold to be considered positive.No anomaly was observed in the repeat test, with a flat curve and no amplification in any of the positive channels, including vic.Low positive samples can occur due to bacterial titers in the specimen being at or near the assay limit of detection.Moreover, limits of detection can vary between assays and verification methods, this may account for the discrepancies observed by the customer.Also, it must be noted that manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.Considering that no other complaint for a similar issue was received for this lot, as well as investigation results, no reagents issue is suspected.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ enteric bacterial panel kit lot 5262914.Conclusion: the root cause was not identified.However, samples at the assay limit of detection (lod) is the most likely cause to explain the customer¿s discrepant results.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action plan since no new hazard was identified.
Event or Problem Description
It was reported that during use of bd max¿ bacterial panel, a false negative salmonella patient result was obtained.The bd max reported a negative result for salmonella spp.Twice, although salmonella grew in culture.Agglutination identified serogroup d, and further diagnostic testing confirmed the isolate as salmonella enteritidis.There was no report of patient impact.This is report 2 of 2.

• Brand Name: BD MAX¿ ENTERIC BACTERIAL PANEL
• Common Device Name: GASTROINTESTINAL PATHOGEN PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 25104820
• Report Number: 3007420875-2026-00113
• Device Sequence Number: 10757253
• Product Code: OOI
• UDI-Device Identifier: 00382904429638
• UDI-Public: (01)00382904429638(17)270515(10)5262914
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K214122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: Other
• Device Catalogue Number: 442963
• Device Lot Number: 5262914
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• 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 Sex: Unknown