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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of bd max¿ enteric bacterial panel, a false positive campylobacter patient result with an unusual pcr curve was obtained.Test was repeated and was campylobacter negative.There was no report of patient impact.
Additional Manufacturer Narrative
D.2.Additional medical device types: pch, pci.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of bd max¿ enteric bacterial panel, a false positive campylobacter patient result with an unusual pcr curve was obtained.Test was repeated and was campylobacter negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation on discrepant results for the campylobacter (campy) target when using the bd max¿ enteric bacterial panel assay (ref.(b)(4)) from lot 5044746 was performed by the review of the manufacturing records, review of customer¿s data and by the complaint¿s history review.The review of quality control records of bd max¿ enteric bacterial panel assay lot 5044746 revealed no anomalies that could explain the customer¿s discrepant results.Customer reported three discrepant samples for the campylobacter (campy) target.The samples gave positive results in the initial tests.Customer mentioned run 688 from bd max¿ instrument (b)(6) as well as runs 814 and 816 from bd max¿ instrument (b)(6) for three suspected campy false positive results; run 688 sample b3, run 814 sample a8 and run 816 sample a8.Customer explained samples obtained negative results upon retest.Customer provided the databases of bd max¿ instrument (b)(6) for investigation.Manual pcr curve adjudication of the positive samples revealed step dislocations in the fam channel (campy target) in the raw signal of all three samples.These atypical curves do not suggest true amplification.Similar step dislocations were observed for salmonella (vic) and shigella (rox) targets but did not cross thresholds to be considered positive.This analysis makes it unlikely that the positive results for the campy target are linked to true amplifications.Nevertheless, 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.Overall, investigation did not allow to identify a cause for these unusual curves causing false results.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on the bd max¿ enteric bacterial panel assay lot 5044746.Based on the investigation performed, no reagent issue is suspected.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa) since no new hazard was identified.

• 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: 24416027
• Report Number: 3007420875-2026-00032
• Device Sequence Number: 10605235
• Product Code: OOI
• UDI-Device Identifier: 00382904429638
• UDI-Public: (01)00382904429638(17)261107(10)5044746
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 5044746
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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