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

Catalog Number 442960

Device Problem False Negative Result (1225)

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

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter prefix: (b)(6).H3: 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 parasite panel, there was one false negative result.No patient impact reported.The following information was provided by the initial reporter: "customer reported contrasting results for cryptosporidium using bd max (negative) compared with two independent methods: qiagen (positive ct 37) and an in-house method (positive ct 33).When did the incident occur? after use.".

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 3007420875-2023-00082 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.

Event Description

It was reporte that while using bd max¿ enteric parasite panel, there was one false negative result.No patient impact reported.The following information was provided by the initial reporter: "customer reported contrasting results for cryptosporidium using bd max (negative) compared with two independent methods: qiagen (positive ct 37) and an in-house method (positive ct 33).When did the incident occur? after use".

• Brand Name: BD MAX¿ ENTERIC PARASITE PANEL
• Type of Device: GASTROINTESTINAL PATHOGEN 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17628221
• MDR Text Key: 322043008
• Report Number: 3007420875-2023-00082
• Device Sequence Number: 1
• Product Code: PCH
• UDI-Device Identifier: 00382904429607
• UDI-Public: 00382904429607
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K143648
• 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: 09/20/2023

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 Expiration Date: 03/17/2024
• Device Catalogue Number: 442960
• Device Lot Number: 2285864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1