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

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	10/23/2024
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 on bd max instrument, 8 samples were false positive for both chlamydia trachomatis and neisseria gonorrhoeae.After inspecting the reagents and instrument, it was visible that a "bloody slime string" from a sample was dragged over the process area and contaminated the samples.Cleaning and environmental testing were performed.Samples were rerun and were negative.There was no report of patient impact.
Additional Manufacturer Narrative
After further evaluation, the previous mfr report # 3007420875-2024-00180 was submitted against wrong product.This report is to be replace by mfr report # 1119779-2025-00272.
Event or Problem Description
It was reported that during use of bd ctgctv2 on bd max instrument, 8 samples were false positive for both chlamydia trachomatis and neisseria gonorrhoeae.After inspecting the reagents and instrument, it was visible that a "bloody slime string" from a sample was dragged over the process area and contaminated the samples.Cleaning and environmental testing were performed.Samples were rerun and were negative.There was no report of patient impact.

• Brand Name: BD CTGCTV2
• Common Device Name: MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD, KIT, NUCLEIC ACID
• 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: 20902537
• Report Number: 3007420875-2024-00180
• Device Sequence Number: 21084031
• Product Code: LSL
• UDI-Device Identifier: 00382904439798
• UDI-Public: (01)00382904439798
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 03/18/2025

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 Catalogue Number: 443979
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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