MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) KIT BD MAX EXT ENTERIC BACTERIAL PANEL; GASTROINTESTINAL PATHOGEN PANEL MULIPLEX NECLEIC ACID-BASED ASSAY SYSTEM

Catalog Number 443812

Device Problem False Negative Result (1225)

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

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).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 kit bd max ext enteric bacterial panel, there was a false negative result for yersinia enterocolitica.There was no report of patient impact.

• Brand Name: KIT BD MAX EXT ENTERIC BACTERIAL PANEL
• Type of Device: GASTROINTESTINAL PATHOGEN PANEL MULIPLEX NECLEIC 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: 19110539
• MDR Text Key: 340900448
• Report Number: 3007420875-2024-00032
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904438128
• UDI-Public: (01)00382904438128
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K214122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

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: 443812
• Device Lot Number: 3346372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2023
• 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