MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ VAGINAL PANEL; VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM

Catalog Number	443712
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.2.Additional medical device types: nsu, ouy, pqa.Investigation summary: the complaint investigation for discrepant results when using the bd max¿ vaginal panel (ref.443712) lot: 5154442 was performed by the review of manufacturing records, review of customer¿s data, retain material testing and by the complaint¿s history review.The customer reported a discrepant result for the same patient on the trichomonas vaginalis (tv) target when tested using two different assays.According to the customer, the issue involved two different swabs collected from the same patient.One swab was tested with the bd max¿ vaginal panel assay (run (b)(4), position a11) and returned a negative tv result, while the other was tested with the bd ctgctv2 for bd max¿ system assay (run (b)(4), position b8) and returned a positive tv result.Both sample buffer tubes (sbts) were retested in run (b)(4), using the same assays as in the original tests.In this repeat run, both tests produced negative tv results (vaginal panel in position b1; ctgctv2 in position a1).Customer provided the database of instrument ct2473 for the investigation.Manual pcr curve adjudication was performed for all four samples.For the original ctgctv2 run (b)(4), which was positive for tv, the amplification curve in the cy5 channel (tv target) showed late and low fluorescence, consistent with a low positive sample.For the sample tested originally with the vaginal panel (run (b)(4), although the result was negative, a slight increase in fluorescence in the fam channel (tv target) at the end of the run was observed, suggesting the presence of target dna at very low levels.Upon repeat testing in run (b)(4), the ctgctv2 assay displayed a late, low-level amplification in the tv target channel that did not cross the threshold, resulting in a negative call.The vaginal panel retest produced a curve similar to the initial result, with a small end-of-run amplification, too low to be considered positive.These findings suggest that the target dna concentration in all the samples may have been at or near both assays limits of detection.Variability in target dna concentration between swabs from a same patient, combined with differences in assay sensitivity, may explain the discrepancies observed by the customer.Moreover, the intended use of each assay should be taken into consideration.According to their respective package inserts, the bd max¿ vaginal panel assay is indicated for vaginal swabs from symptomatic patients with vaginitis/vaginosis, whereas the bd ctgctv2 for bd max¿ system assay can be used with both symptomatic and asymptomatic individuals.Nevertheless, manual curve adjudication has limitations; visual examination of pcr curves for low signal is a conservative assessment of the data.The retain material of bd max¿ vaginal panel from lot: 5154442 was tested and the results were as expected.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ vaginal panel lot: 5154442.Overall, based on the investigation, samples near the assay limit of detection combined with differences in assay design and intended use are the most likely causes to explain the customer¿s discrepant results.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 a preventive action plan since no new hazard identified.
Event or Problem Description
It was reported that during use of bd max¿ vaginal panel, a trichomonas vaginalis (tv) false negative patient result was obtained.Another swab from the same patient was tested on bd max¿ ctgctv, and the tv result was positive.There was no report of patient impact.

• Brand Name: BD MAX¿ VAGINAL PANEL
• Common Device Name: VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM
• 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: 24664960
• Report Number: 3007420875-2026-00064
• Device Sequence Number: 9344678
• Product Code: OOI
• UDI-Device Identifier: 00382904437121
• UDI-Public: (01)00382904437121(17)260616(10)5154442
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K201017
• 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
• Report Date (Section B): 03/16/2026

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: 06/16/2026
• Device Catalogue Number: 443712
• Device Lot Number: 5154442
• 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: 02/26/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• 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