MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD CTGCTV2 FOR BD MAX¿ SYSTEM; MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD KIT

Catalog Number	443979
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2.Additional medical device types: mkz, ouy, qep.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 ctgctv2 for bd max¿ system, a trichomonas vaginalis false positive patient result was obtained.There was no report of patient impact.
Event or Problem Description
It was reported that during use of bd ctgctv2 for bd max¿ system, a trichomonas vaginalis 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 bd cor¿ ctgctv2 (ref.(b)(4)) from lot 4234115 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Customer reported a suspected false tv positive sample linked to an unusual curve with bd cor¿ ctgctv2 (ref# (b)(4)) kit lot 4234115.Review of the manufacturing records of individual kit lots components indicates that those lots were manufactured according to specifications and met performance requirements.Customer provide the run (b)(6) that includes the specific sample mentioned in the complain text and it was investigated.The run was analyzed and manual pcr curve adjudication of the positive sample revealed step dislocations in the cy5 channel (tv target) in both the raw and background signals.This atypical curve does not suggest true amplification.Furthermore, similar step dislocations were observed across the four other channels giving positive result for the internal control (rox channel) and one of the gc targets (cy5.5 channel).This makes it unlikely that the tv target positive result is a true amplification.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 the bd cor¿ ctgctv2 lot used by the customer.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 since no new hazard was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.

• Brand Name: BD CTGCTV2 FOR BD MAX¿ SYSTEM
• Common Device Name: MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD KIT
• 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: 22531884
• Report Number: 3007420875-2025-00112
• Device Sequence Number: 8017955
• Product Code: LSL
• UDI-Device Identifier: 00382904439798
• UDI-Public: (01)00382904439798(11)240821(17)251114(10)4234115
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210585
• 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): 08/20/2025

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: 11/14/2025
• Device Catalogue Number: 443979
• Device Lot Number: 4234115
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2024
• 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