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

Catalog Number	437519
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 false negative gonorrhoeae patient result was obtained.The patient's urethral sample was taken on eswab and transferred to bd max tube.On the first run a single gc target was amplified but with an unusual pcr curve.Sample was cultured and was positive.Direct examination (gram) also revealed the presence of a gonococcus.Sample was run on a brucker maldi toff, also confirming the presence of gonococcus.Sample was run again diluted and undiluted on bd max, both with positive results.There was no report of patient impact.
Event or Problem Description
It was reported that during use of bd pcr cartridge on the bd max¿ system, a false negative gonorrhoeae patient result was obtained.The patient's urethral sample was taken on eswab and transferred to bd max tube.On the first run a single gc target was amplified but with an unusual pcr curve.Sample was cultured and was positive.Direct examination (gram) also revealed the presence of a gonococcus.Sample was run on a brucker maldi toff, also confirming the presence of gonococcus.Sample was run again diluted and undiluted on bd max, both with positive results.There was no report of patient impact.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information: b.2.Describe event or problem : it was reported that during use of bd pcr cartridge on the bd max¿ system, a false negative gonorrhoeae patient result was obtained.The patient's urethral sample was taken on eswab and transferred to bd max tube.On the first run a single gc target was amplified but with an unusual pcr curve.Sample was cultured and was positive.Direct examination (gram) also revealed the presence of a gonococcus.Sample was run on a brucker maldi toff, also confirming the presence of gonococcus.Sample was run again diluted and undiluted on bd max, both with positive results.There was no report of patient impact.D.2.Medical device types: ooi; njr, d.4.Medical device material number: 437519, d.4.Medical device brand name: bd pcr cartridge, d.4.Medical device common name: thermal cycler nucleic acid amplification analyser ivd, laboratory, d4.Medical device lot number: 4149768, d.4.Medical device udi: (b)(4), d.4.Medical device expiration date: 06/17/2026, g.1.Pma / 510(k)#: k111860, h.4.Device manufacture date: 05/28/2024.Investigation summary: the complaint investigation for discrepant results for the neisseria gonorrhea (gc) target with bd pcr cartridges (ref#(b)(4)) lot 4149768 was performed by review of customer¿s data and by the complaint¿s history review.Customer reported a false negative result for gc target when using the bd max¿ ctgctv2 assay with bd pcr cartridges from lot 4149768.Customer provided partial scans of pdf report of runs 1033, 1037 and 1038 from bd max¿ instrument ct164 for investigation.Customer identified sample b10 (run 1033) as the discrepant negative result for the gc target.Runs 1037 (sample a12) and 1038 (sample b1) were repeat tests of this sample and both gave positive results for the gc target.Manual pcr curves adjudication revealed fluorescence drift in the cy5.5 channel (2nd gc target) for samples b10 (run 1033) and a12 to a lesser extent (run 1037), while sample b1 (run 1038) showed expected amplification curve.Since cartridges from lot 4149768 were used for runs 1033 and 1037, while lot 4341137 was used for run 1038, it is suspected that the signal drift observed with cartridges from lot 4149768 contributed to the false negative result obtained by the customer in run 1033 for sample b10.The bd pcr cartridges (ref.437519) lot 4149768 has been identified as potentially depicting unusual curves presenting an upward drift.The root cause for the cy5 signal drift issue associated with the bd pcr cartridges lot 4149768 was identified during corrective and preventive action investigation.A change in the adhesive supplier by bd¿s pcr cartridge label suppliers was identified as the root cause for the observed issue.Actions were taken both internally at bd and externally with our suppliers to prevent the recurrence of this product issue.Bd confirms the complaint based on the investigation that was performed.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.

• Brand Name: BD PCR CARTRIDGE
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22323031
• Report Number: 3007420875-2025-00096
• Device Sequence Number: 18341409
• Product Code: OOI
• UDI-Device Identifier: 30382904375196
• UDI-Public: (01)30382904375196(17)260617(10)4149768
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111860
• 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): 08/28/2025

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: 06/17/2026
• Device Catalogue Number: 437519
• Device Lot Number: 4149768
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• 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