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

Model Number 442963

Device Problem False Positive Result (1227)

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

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

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 bd max¿ enteric bacterial panel several false positives have occurred.The following information was provided by the initial reporter: max ebp - 442963_unknown - fp.Jagged curves.

Event Description

It was reported that bd max¿ enteric bacterial panel several false positives have occurred.The following information was provided by the initial reporter: max ebp - 442963_unknown - fp.Jagged curves.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 3007420875-2022-00085 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.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16078219
• MDR Text Key: 308450466
• Report Number: 3007420875-2022-00085
• Device Sequence Number: 1
• Product Code: PCI
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K140111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/03/2024
• Device Model Number: 442963
• Device Catalogue Number: 442963
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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