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	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Report 2 of 6: it was reported that during use of bd max¿ enteric bacterial panel, a false positive salmonella patient result was obtained.Max test was repeated and was salmonella 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
Report 2 of 6: it was reported that during use of bd max¿ enteric bacterial panel, a false positive salmonella patient result was obtained.Max test was repeated and was salmonella negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results with the bd max¿ enteric bacterial panel kit (ref.442963) lot 4353348 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Customer complained about six samples that gave discrepant positive results for salmonella (salm) and/or campylobacter (campy) targets when using the bd max¿ enteric bacterial panel kit lot 4353348.The review of manufacturing records of bd max¿ enteric bacterial panel indicated that lot 4353348 was manufactured according to specifications and met performance requirements.Customer provided run reports (pdf) for runs 2601, 2602 and 2603 from bd max¿ instrument ct0506 for investigation.Customer identified the six discrepant samples as samples with last four digits (b)(6) (positions a7 (run (b)(6)), a4 (run (b)(6)), b2 (run (b)(6)), (b)(6) (positions b9 (run (b)(6)), b4 (run (b)(6)), b11 ((b)(6)), (b)(6) (positions a10 (run (b)(6)), b9 (run (b)(6)), a1 (run (b)(6)), (b)(6) (positions b10 (run (b)(6)), b12 (run (b)(6)), a3 (run (b)(6)), (b)(6) (positions a9 (run (b)(6)), b8 (run (b)(6)), a9 (run (b)(6)) and (b)(6) (positions b2 (run (b)(6)), b10 (run (b)(6)).A limited manual pcr curve adjudication of the discrepant samples from the pdf reports was performed and revealed that all the samples obtained late and low but true amplification in the vic channel (salm target) in their initial runs.Upon repeat testing, sample (b)(6) obtained late and low but true amplification in the fam channel (campy target) but was negative for the salm target both times and sample (b)(6) showed late and low amplification in the vic channel (salm target) on the first repeat test but was negative on the second repeat test, while the four other samples gave negative results.Analysis also revealed a strong positive sample for the salm target in run (b)(6) (position a5), and it is suspected that cross-contamination during sample preparation could explain the customer discrepant results for the salm target in runs (b)(6).Regarding sample (b)(6) with positive campy target result in runs (b)(6), specimens at or near the assay limit of detection (lod), as well as environmental contamination, are the most likely causes to explain the customer¿s discrepant results.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¿ enteric bacterial panel kit lot 4353348.The root cause was not identified.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 or trends was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.

• 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: 22287249
• Report Number: 3007420875-2025-00091
• Device Sequence Number: 15547136
• Product Code: OOI
• UDI-Device Identifier: 00382904429638
• UDI-Public: (01)00382904429638(11)241218(17)260718(10)4353348
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 08/27/2025

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: Other
• Device Expiration Date: 07/18/2026
• Device Catalogue Number: 442963
• Device Lot Number: 4353348
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2024
• 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
• Patient Sex: Unknown