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	08/05/2024
Type of Reportable Event	Malfunction
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
Report 2 of 2: it was reported that during use of bd max¿ gbs, a false positive gbs patient result was obtained.Repeat testing was performed on max from a new sample, and the result was negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant results when using the bd max gbs kit (ref.441772) lot 4054181 was performed by the review of manufacturing records, review of customer¿s data and by the complaint¿s history review.Customer complained about obtaining positive results that repeated negative when using bd max¿ gbs kit lot 4054181 for two samples.Repeats were performed from a new sbt using the same lim broth preparation.Review of manufacturing records of the bd max gbs indicated that the lot 4054181 was manufactured according to specifications and met performance requirements.Customer provided runs 2853, 2854, 3890 and 3891 from instrument ct1273 for investigation.Customer identified positive samples in run 2853; positions a4 and a5 that repeated negative in run 2854; positions a7 and a8 as to be investigated.Manual pcr curve adjudication was conducted across the discrepant samples.Original tests showed late amplification of the gbs target in the fam channel, which is unexpected with the bd max¿ gbs assay, since samples are tested following an enrichment step.No amplification in the fam channel (gbs target) was observed for all the repeat tests, and a negative result is the expected result in such cases.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 reagent issue based on the analysis of the complaints received for discrepant results on bd max gbs lot 4054181.Bd cannot confirm the complaint based on the investigation that was performed.However, cross-contamination during sample preparation could explain the customer¿s issue.Bd did not initiate a corrective and a preventive action plan since no new hazard or trends was identified.Bd quality will continue to monitor for trends.
Event or Problem Description
Report 2 of 2: it was reported that during use of bd max¿ gbs, a false positive gbs patient result was obtained.Repeat testing was performed on max from a new sample, and the result was negative.There was no report of patient impact.

• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20145860
• Report Number: 3007420875-2024-00074
• Device Sequence Number: 4275511
• Product Code: OOI
• UDI-Device Identifier: 00382904417727
• UDI-Public: (01)00382904417727(11)240223(17)250920(10)4054181
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/29/2024

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
• Operator of Device: Other
• Device Expiration Date: 09/20/2025
• Device Catalogue Number: 441772
• Device Lot Number: 4054181
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2024
• 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