MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ GBS; NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS, DIRECT SPECIMEN

Catalog Number	441772
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of bd max¿ gbs, a false positive result was obtained.There was no report of patient impact.
Additional Manufacturer Narrative
D.2.Additional medical device type: njr.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 max¿ gbs, a false positive result was obtained.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for false positive results when doing negative qc testing with the bd max¿ gbs assay (ref.441772) lot 5029035 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.The review of quality control records of bd max¿ gbs assay lot 5029035 revealed no anomalies that could explain the customer¿s false positive results.Customer provided the database for instrument ct0264 along with run files (pdf and csv) for runs 1576 and 1577 for investigation.Based on the database and run file review, four samples using lot 5029035 were identified with positive results: positions a10 (run 1442), a10 (run 1452), b9 (run 1470), and a10 (run 1483).Manual pcr curve adjudication was performed on all four samples, revealing late and low, but true, amplification of the gbs target in the fam channel.These samples were repeated on the same day with the same kit lot, different sbt, and all had an expected negative result.Data analysis suggests that positive results in negative controls are not a new issue for this customer.Such results have been observed since at least 2024 and across multiple kit lots, confirming that the customer¿s issue is not lot specific.A negative result upon repeat was obtained for all 24 unexpected positive results for negative controls recorded since 2024 on initial test.This suggests that the issue likely occurs during the preparation of the two controls, positive and negative, as they are always together in the same run.In contrast, the repeat tests always contain solely the defective negative control.Moreover, a bd associate visiting on site made two runs on (b)(6) 2025, one with known negative patient samples and one from negative control samples made using 15ul of lim broth in sbt, with a different kit lot, in runs 1576 and 1577, and the results were negative.Presence of only expected results in these two runs suggests the issue may be isolated to specific events.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves is a conservative assessment of the data.Based on the data and information provided, cross contamination introduced during samples control preparation at the customer¿s site is the most likely cause to explain the unexpected positive results.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ gbs lot 5029035.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 MAX¿ GBS
• Common Device Name: NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS, DIRECT SPECIMEN
• 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: 23302817
• Report Number: 3007420875-2025-00184
• Device Sequence Number: 20049517
• Product Code: OOI
• UDI-Device Identifier: 00382904417727
• UDI-Public: (01)00382904417727(17)260718(10)5029035
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 07/18/2026
• Device Catalogue Number: 441772
• Device Lot Number: 5029035
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• 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