MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ EXK¿ DNA-3; CLINICAL SAMPLE CONCENTRATOR

Catalog Number	442821
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using kit bd max exk dna-3 usa discrepant results were obtained for c.Auris.
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 when using kit bd max exk dna-3 usa discrepant results were obtained for c.Auris.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results with the bd max exk dna-3 usa kit (ref.442821) lot 4194213 was performed by the review of manufacturing records, analysis of customer¿s data and the verification of complaints history.Review of manufacturing records of the bd max exk dna-3 usa kit indicated that the lot 4194213 was manufactured according to specifications and met performance requirements.Customer reported discrepant results between two bd max¿ instruments (ct3122 and ct3158) when using the bd max¿ exk¿ dna-3 kit in combination with their c.Auris assay.Customer provided the two databases from bd max¿ instruments ct3122 and ct3158 for investigation.Analysis of database from both bd max¿ instruments revealed one sample with a positive result in run #48 on bd max¿ instrument ct3122 (position b8) and a negative result in run #37 on bd max¿ instrument ct3158 (position b8).Manual pcr curve adjudication was performed and revealed a true amplification for this sample on both runs in 585/630 excitation/emission channel.The sample tested on bd max¿ instrument ct3122 obtained an amplification with a ct of 27, while the same sample tested on bd max¿ instrument ct3158 obtained late and low amplification with a ct around 38.Customer udp is set to give a positive result when the amplification ct is equal or lower than 28.Curve analysis in 680/715 excitation/emission channel revealed late amplification of the spc target for the sample tested on bd max¿ instrument ct3158.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.There is no indication of a bd reagent issue based on the analysis of the complaints received for discrepant results on bd max exk dna-3 usa kit lot 4194213.The root cause was not identified.However, specimen at or near the assay limit of detection (lod), or specimen-associated inhibition, are the most likely causes to explain the customer¿s discrepant results.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa) 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 MAX¿ EXK¿ DNA-3
• Common Device Name: CLINICAL SAMPLE CONCENTRATOR
• 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: 22021913
• Report Number: 3007420875-2025-00075
• Device Sequence Number: 9485008
• Product Code: JJH
• UDI-Device Identifier: 00382904428211
• UDI-Public: (01)00382904428211(11)240712(17)260110(10)4194213
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 08/01/2025

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: 01/10/2026
• Device Catalogue Number: 442821
• Device Lot Number: 4194213
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2024
• 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