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

Device Problem False Positive Result (1227)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

D2.Additional medical device type: ooi.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while testing with the bd max¿ gbs, a false positive result was obtained.A confirmatory culture was performed and resulted as negative.There was no report of patient impact.Report 1 of 3.

Event Description

It was reported that while testing with the bd max¿ gbs, a false positive result was obtained.A confirmatory culture was performed and resulted as negative.There was no report of patient impact.Report 1 of 3.

Manufacturer Narrative

Investigation summary the complaint investigation for discrepant results when using the bd max gbs kit (ref.441772) lot 3291548 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Customer complained about discrepancies between gbs target results obtained with bd max¿ gbs kit lots 3291548 and culture for one patient.Review of manufacturing records of the bd max gbs indicated that the lot 3291548 was manufactured according to specifications and met performance requirements.Customer provided the scanned first page of run reports (b)(4) and (b)(4) from instrument (b)(4), and culture results report from an external laboratory for investigation.Customer¿s notation on the reports allowed to identify the affected samples as samples a7 (run (b)(4) and b5 (run (b)(4).Analysis of the runs revealed that both these samples were from the same patient and gave positive results.Run (b)(4) was performed on b)(6) 2024 and run (b)(4) on (b)(6) 2024.Since sample b5 (run (b)(4) sbt was tested outside of bd¿s recommended stability window (4h), it is considered invalid and should have been repeated with a new sbt.Analysis of the culture report revealed that the patient obtained a positive result with the strep b carrot broth¿ test, which was sent to another laboratory for culture testing and then gave a culture negative result for gbs.Limit of detection can vary between different method of detection.Despite multiple attempts made to receive information from the customer, no data was provided for the investigation.Without data, bd is unable to identify the cause of the customer issue.The root cause was not identified.However, specimen at or near the assay limit of detection (lod) of the laboratory culture method could explain the customer¿s discrepant 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 3291548.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 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¿ GBS
• Type of Device: 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): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19013475
• MDR Text Key: 339129481
• Report Number: 3007420875-2024-00028
• Device Sequence Number: 1
• Product Code: NJR
• UDI-Device Identifier: 00382904417727
• UDI-Public: (01)00382904417727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111860
• 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
• Report Date: 03/11/2024

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: 441772
• Device Lot Number: 3291548
• 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
• 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