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

Catalog Number	443812
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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¿ ext enteric bacterial panel, a vibrio false positive patient result was obtained.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results when using the bd max¿ extended enteric bacterial panel (xebp) assay (ref.(b)(4)) kit lot 5231261 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.The review of quality control records of bd max¿ xebp lot 5231261 revealed no anomalies that could explain the customer¿s discrepant results.Customer questioned the positive vibrio results for four samples processed on bd max¿ instrument (b)(6): run 92 (a2), run 93 (a6), run 95 (b5), and run 100 (a10), obtained in a short period of time (from february 6th to 8th).Pcr curve adjudication of the vibrio positive samples revealed late and low but appearing to be true vibrio positive amplifications.Low positives samples, such as the ones investigated herein can occur due to bacterial titers in the specimen being at or near the limit of detection of the assay or through environmental or cross contamination introduced during the sample preparation at the customer¿s site.The total rate of positive vibrio samples for the current complaint kit lot 5231261 is (b)(4) (15/2383) while the rate of all other lots , used by the customer, is (b)(4) (6/835), suggesting the reagent is not suspected to be an issue.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max xebp assay lot 5231261.The root cause was not identified.However, specimens at or near the assay limit of detection (lod), as well as environmental or cross contamination could explain the customer¿s discrepant result.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action since no new hazard was identified.
Event or Problem Description
It was reported that during use of bd max¿ ext enteric bacterial panel, a vibrio false positive patient result was obtained.There was no report of patient impact.

• Brand Name: BD MAX¿ EXT 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: 24547079
• Report Number: 3007420875-2026-00050
• Device Sequence Number: 9272073
• Product Code: PCH
• UDI-Device Identifier: 00382904438128
• UDI-Public: (01)00382904438128(17)270220(10)5231261
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 03/18/2026

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: 443812
• Device Lot Number: 5231261
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2025
• 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