MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD CTGCTV2; THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY

Catalog Number	443904
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
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, a false positive chlamydia trachomatis patient result was obtained.Sample was retested on max again and the result was negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for a discrepant result when using the bd max ctgctv2 kit (ref.443904) lot 4054266 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Customer complained about obtaining a positive result for the ct target that repeated negative when using bd max¿ ctgctv2 kit lot 4054266.Repeats were performed from the same sbt.Review of manufacturing records of the bd max ctgctv2 indicated that the lot 4054266 was manufactured according to specifications and met performance requirements.Customer provided runs 3869, 3872, 3881 and 3883 and database from instrument ct1273 for investigation.Customer identified positive sample in run 3881; position a8 that repeated negative in run 3883; position b7 as to be investigated.Manual pcr curve adjudication was conducted across the discrepant samples.Late and low, but true amplification of the ct target in the fam channel for the original test.No amplification in the fam channel (ct target) was observed for the repeat test, and a negative result is the expected result in such cases.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 ctgctv2 lot 4054266.Bd cannot confirm the complaint based on the investigation that was performed.However, specimens at or near the assay limit of detection (lod), or environmental or cross contamination could explain the customer¿s issue.Bd did not initiate a corrective and a 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.
Event or Problem Description
It was reported that during use of bd ctgctv2, a false positive chlamydia trachomatis patient result was obtained.Sample was retested on max again and the result was negative.There was no report of patient impact.

• Brand Name: BD CTGCTV2
• Common Device Name: THERMAL CYCLER NUCLEIC ACID AMPLIFICATION ANALYSER IVD, LABORATORY
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20214082
• Report Number: 3007420875-2024-00077
• Device Sequence Number: 20633614
• Product Code: LSL
• UDI-Device Identifier: 00382904439040
• UDI-Public: (01)00382904439040
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K182692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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: 12/20/2025
• Device Catalogue Number: 443904
• Device Lot Number: 4054266
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• 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