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 Positive Result (1227)

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

Event Date 10/24/2023

Event Type  malfunction  

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 kit bd max ext enteric bacterial panel false positives were obtained.This occurred 3 times.No patient impact reported.The following information was provided by the initial reporter: there are three samples where vibrio spp target is flagged as positive.The curves are not compatible with positive ones.

Manufacturer Narrative

H6: investigation summary: the complaint investigation for discrepant results with the bd max¿ extended enteric bacterial panel kit (ref.(b)(4)) lot 3172074 was performed by the review of manufacturing records, review of customer¿s data and verification of complaints history.The review of manufacturing records of bd max¿ extended enteric bacterial panel indicated that lot 3172074 was manufactured according to specifications and met performance requirements.Customer complained about suspected false vibrio positive results for 3 samples tested with bd max¿ ext enteric bacterial panel kit lot 3172074.According to the customer, the curves obtained for these 3 samples are unusual and do not appear to be a true positive result.Despite multiple attempts made to receive information from the customer, no data or additional information was provided for the investigation.Without data, bd is unable to identify the cause of the customer issue.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant results on bd max¿ extended enteric bacterial panel kit lot 3172074.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.Bd quality will continue to monitor for trends.

Event Description

It was reported that while using kit bd max ext enteric bacterial panel false positives were obtained.This occurred 3 times.No patient impact reported.The following information was provided by the initial reporter: there are three samples where vibrio spp target is flagged as positive.The curves are not compatible with positive ones.

• 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: 18125689
• MDR Text Key: 328050234
• Report Number: 3007420875-2023-00104
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904438128
• UDI-Public: (01)00382904438128
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K170308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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: Health Professional
• Device Catalogue Number: 443812
• Device Lot Number: 3172074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• 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