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 03/20/2024

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 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 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.

Manufacturer Narrative

H.6 investigation summary: the complaint investigation for discrepant results when using the bd max gbs ((b)(4)) 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
• 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): 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
• MDR Text Key: 340465873
• Report Number: 3007420875-2024-00037
• 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: 04/12/2024

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: 3291340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/17/2024
• 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