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

Catalog Number	442960
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2.Additional medical device type: pch.E.1.Initial reporter phone number: (b)(6).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 the bd max¿ enteric parasite panel, a giardia lamblia false positive patient result with an noisy pcr curve 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¿ enteric parasite panel assay (ref# 442960) lot 4233950 was performed by the review of manufacturing records, customer¿s data analysis and verification of complaints history.Review of manufacturing records of bd max¿ enteric parasite panel assay indicated that the lot 4233950 was manufactured according to specifications and met performance requirements.Customer complained about a suspected false positive result for the g.Lambia target when using bd max¿ enteric parasite panel kit lot 4233950 and provided a picture of run #1457 which contained nine samples for investigation.The sample suspected of being false positive by the customer is in position b1.The corresponding curves for this sample were isolated on the picture report provided by the customer and revealed steps dislocations around cycle 40 in fam and rox channels that reached the threshold to give a positive result in the fam channel (glam target).Based on the investigation, it is unlikely that this positive result is true amplification.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.Since the customer did not mention any other event and considering that no other complaint for discrepant results issues was received on this lot, this may have been an isolated issue, and a root cause could not be identified.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ enteric parasite panel assay lot 4233950.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 (capa) 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 the bd max¿ enteric parasite panel, a giardia lamblia false positive patient result with an noisy pcr curve was obtained.There was no report of patient impact.

• Brand Name: BD MAX¿ ENTERIC PARASITE 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: 21899820
• Report Number: 3007420875-2025-00066
• Device Sequence Number: 21014812
• Product Code: OOI
• UDI-Device Identifier: 00382904429607
• UDI-Public: (01)00382904429607(11)240820(17)260314(10)4233950
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K220193
• 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): 06/16/2025

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: 03/14/2026
• Device Catalogue Number: 442960
• Device Lot Number: 4233950
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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