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	03/20/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that during use with the bd max¿ gbs assay, there was a false positive result.There was no report of patient impact.Report 5 of 5.
Event or Problem Description
It was reported that during use with the bd max¿ gbs assay, there was a false positive result.There was no report of patient impact.Report 5 of 5.
Additional Manufacturer Narrative
H.6 investigation summary: the complaint investigation for discrepant results when using the bd max gbs (ref 441772) lot 3291340 was performed by the review of manufacturing records and by the complaint¿s history review.Customer complained about a negative qc control testing as positive when using the bd max gbs lot 3291340.The run contained 7 samples (5 patients; 1 negative control; 1 positive control) and all turned out positive.Review of the manufacturing records of the bd max gbs lot 3291340 indicated that the lot was manufactured according to specifications and met performance requirements.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, environmental contamination or sample cross-contamination could explain the customer¿s discrepant results.Detailed instructions for extended environmental run and cleaning steps were provided to the customer.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant on bd max gbs lot 3291340.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
• 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: 19127262
• Report Number: 3007420875-2024-00037
• Device Sequence Number: 15511382
• Product Code: NJR
• UDI-Device Identifier: 00382904417727
• UDI-Public: (01)00382904417727
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2024

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: 04/26/2025
• Device Catalogue Number: 441772
• Device Lot Number: 3291340
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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