MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX¿ ENTERIC BACTERIAL PANEL; GASTROINTESTINAL BACTERIAL PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM

Catalog Number 442963

Device Problem False Negative Result (1225)

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

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

E.1.(b)(6).H.3.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

2 of 2.It was reported that patient samples tested with the bd max¿ enteric bacterial panel gave false negative results for salmonella and campylobacter.Samples were not reported out so there was no patient impact.Confirmatory tests were performed: sample 2: positive antigen test.

Manufacturer Narrative

H6.Investigation summary: the complaint investigation for discrepant results when using the bd max¿ enteric bacterial panel assay (ref.(b)(4)) from lot 3172498 was performed by the review of the manufacturing records, retain material testing, review of customer¿s data and by the complaint¿s history review.Review of the manufacturing records of bd max¿ enteric bacterial panel assay indicated that lot 3172498 was manufactured according to specifications and met performance requirements.The retain material of bd max¿ enteric bacterial panel (ebp) assay from lot 3172498 was tested and the results were as expected, without any anomaly.The reagents performed within specifications.Customer complained about discrepancies for two distinct samples when compared with alternate methods.A first sample received a negative result for salmonella target but tested positive by conventional culture while a second sample received a negative result for campylobacter target but resulted in a positive with an antigen test.Customer provided no further information concerning the specific samples involved in the issue, and specific analysis could not be performed.However, customer provided the database from instrument ct0543 for investigation.Manual pcr curve adjudication was conducted across all samples tested with bd max¿ ebp assay kit lot #3172498.Analysis of pcr curves of all samples showed no sign of pcr amplification for any ebp targets, and a strong amplification of internal control (cy5.5 channel), resulting in negative results, without anomaly.Based on this curves analysis, no reagents issue for any of the samples is suspected.According to this data and considering the fact the retain material testing showed that kit lot #3172498 still performs as expected, no reagents issue is suspected.Overall, based on the investigation and available information, the root cause was not identified.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on the bd max¿ enteric bacterial panel assay lot 3172498.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action (capa) since no new hazard was identified.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.H3 other text : see h10.

Event Description

2 of 2 it was reported that patient samples tested with the bd max¿ enteric bacterial panel gave false negative results for salmonella and campylobacter.Samples were not reported out so there was no patient impact.Confirmatory tests were performed: sample 2: positive antigen test.

• Brand Name: BD MAX¿ ENTERIC BACTERIAL PANEL
• Type of Device: GASTROINTESTINAL BACTERIAL PANEL MULTIPLEX NUCLEIC ACID-BASED ASSAY SYSTEM
• 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: 18275221
• MDR Text Key: 329841982
• Report Number: 3007420875-2023-00117
• Device Sequence Number: 1
• Product Code: PCI
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K140111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 442963
• Device Lot Number: 3172498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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