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 Positive Result (1227)

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

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

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

It was reported that while using bd max¿ enteric bacterial panel, there was a discrepant mrsa result.Patient was treated with antibiotics.No treatment results reported.

Event Description

It was reported that while using bd max¿ enteric bacterial panel, there was a discrepant mrsa result.Patient was treated with antibiotics.No treatment results reported.

Manufacturer Narrative

The following fields have been updated with corrected and/or additional information: d4: medical device lot #: 3137729 d4.Medical device expiration date: 30-nov-2024 h4.Device manufacture date: (b)(6) 2023 h6: investigation summary: the complaint investigation for discrepant results when using the bd max¿ enteric bacterial panel assay (ref.(b)(4)) from lot 3137729 was performed by the review of the manufacturing records, 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 3137729 was manufactured according to specifications and met performance requirements.Customer complained about a false positive result when using the bd max¿ enteric bacterial panel kit lot 3137729.The sample gave a positive result for 3 targets (shig, stx and salm) whereas it gave a negative result when using other pcr and culture methods.Customer provided run 887 from instrument (b)(6) and run 10147 from instrument (b)(6) for investigation.Manual pcr curve adjudication was performed across two positive samples: b3 in run 8847/instrument (b)(6) and a12 in run 10147/instrument (b)(6).Pcr curve analysis revealed that in both runs, the same sample gave positive results for the same targets, and these positive results all displayed atypical linear curves in the corresponding channels, which are unlikely to be true positive results.It must be noted that manual pcr curve adjudication and visual examination of atypical pcr curves is a conservative assessment of the data.Since the sample was tested 2 times on two different bd max instruments, the issue is not suspected of being linked to the reagents.The issue is suspected of being linked to the sample itself, as it may contain interfering substances.The root cause of the positive customer¿s result 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 3137729.Bd cannot confirm the complaint based on the investigation that was performed.H3 other text : see h.10.

• 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): 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: 18282259
• MDR Text Key: 329936737
• Report Number: 3007420875-2023-00118
• Device Sequence Number: 1
• Product Code: PCI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 442963
• Device Lot Number: 3137729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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
• Patient Outcome(s): Other