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

Device Problems False Positive Result (1227); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported that during use with the bd max¿ vaginal panel, a sample was positive for both bv group and c group.Upon repeat, only bv came back positive.There was no report of patient impact.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields have been updated with corrected and/or additional information: h6: imdrf annex a grid: a090804 - false positive result (1227) b3: date of event 04-mar-2024.

Event Description

It was reported that during use with the bd max¿ vaginal panel, a sample was positive for both bv group and c group.Upon repeat, only bv came back positive.There was no report of patient impact.

Event Description

It was reported that during use with the bd max¿ vaginal panel, a sample was positive for both bv group and c group.Upon repeat, only bv came back positive.There was no report of patient impact.

Manufacturer Narrative

H.6 investigation summary: the complaint investigation for discrepant results when using the bd max vaginal panel kit (ref.443712) kit lot 3291361 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Customer complained about discrepant results on for the cgroup target when using the bd max vaginal panel kit lot 3291361.Review of the manufacturing records of bd max vaginal panel kit indicated that lot 3291361 was manufactured according to specifications and met performance requirements.Scans of the runs 5090 (bd max ct1699) and 2566 (bd max ct2003) were provided by the customer and analyzed.Sample in run 5090; position a6 that gave a cgoup positive result was repeated in run 2566; position b1 and gave a cgoup negative result.Analysis of the curves from the pdf report revealed a late amplification in the rox channel in bottom position (cgroup target) for the sample in position a6 in run 5090.In run 2566, no amplification in that channel was observed for the sample in position b1.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max vaginal panel kit lot 3291361.The root cause was not identified.However, a sample at the assay limit of detection (lod) could explain the customer issue.Indeed, a low positive sample could generate variable results when repeated.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 or trends was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.

• Brand Name: BD MAX¿ VAGINAL PANEL
• Type of Device: 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19012599
• MDR Text Key: 339156338
• Report Number: 3007420875-2024-00025
• Device Sequence Number: 1
• Product Code: PQA
• UDI-Device Identifier: 00382904437121
• UDI-Public: (01)00382904437121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

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
• Device Operator: Other
• Device Catalogue Number: 443712
• Device Lot Number: 3291361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1