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	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2.Additional medical device types: pch, pci.Investigation summary: the complaint investigation for discrepant results with the bd max¿ enteric bacterial panel kit (ref.442963) from lot 5044742 was performed by the review of the manufacturing records, retain material testing, review of customer¿s data and verification of complaints history.The review of quality control records of bd max¿ enteric bacterial panel (ebp) kit lot 5044742 revealed no anomalies that could explain the customer¿s discrepant results.Retain material of bd max¿ ebp kit lot 5044742 was tested the results were as expected.Customer provided two reports of runs 2982 and 2984 from instrument ct1889 for investigation.Customer complained about discrepant results for the salm target.In one instance, the sample gave a negative result for the salm target, associated to a late, but valid ct, for the internal control (ic) target in top position of the cartridge, while being unresolved (unr) in the bottom position of the cartridge (bd max¿ ext enteric bacterial panel (xebp)).Upon repeat of this sample from a new sample buffer tube (sbt), a positive salm target result was obtained.Customer questions why the assay algorithm considered one of the ic target in the initial test, which has a late ct, as valid (top position), while the other ic target is unr (bottom position).Affected samples were identified in positions a11 (run 2982) and b11 (run 2984).Limited pcr curves adjudication was performed for the curves in top position of the cartridge and revealed no amplification in the vic channel (salm target) for sample a11, and late and low amplification in the cy5.5 channel (ic target) that reached the threshold to give a valid result.In the bottom position of the cartridge, no amplification was observed, for all the channels.A negative result for the salm target was the expected result in such a case, as well as unr results for xebp targets, without anomaly, since the validity of the results is determined based on a per master mix basis.The assays algorithm was designed this way and performed as expected.An inhibitory sample is suspected of being the cause of the issue.Based on the xebp package insert instructions (pi; (b)(4)), when a complete or partial unr result is obtained, a repeat test must be performed, which will include the ebp assay, regardless of its ic target result.Moreover, in the event of discrepant results occurring during a repeat test, any positive result must be retained.As a result, sample b11 (repeat from new sbt), which showed sigmoidal amplification curves in the vic (salm target) and cy5.5 (ic target) channels, obtained a positive salm target result in the repeat test and should be considered as the final result.Based on the investigation and information provided, 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 from lot 5044742.The root cause was not identified, and bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action since no trend was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.
Event or Problem Description
It was reported that during use of bd max¿ enteric bacterial panel, a false negative salmonella patient result was obtained.The first max test was salmonella negative, and the repeat max test was salmonella positive.There was no report of patient impact.

• 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: 23706462
• Report Number: 3007420875-2025-00224
• Device Sequence Number: 10691207
• Product Code: OOI
• UDI-Device Identifier: 00382904429638
• UDI-Public: (01)00382904429638(17)260926(10)5044742
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 11/07/2025

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: 09/26/2026
• Device Catalogue Number: 442963
• Device Lot Number: 5044742
• 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: 11/07/2025
• Initial Report FDA Received Date: 12/03/2025
• 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