MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PANEL PHOENIX NMIC/ID-307; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY

Catalog Number 449289

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

It was reported that during use with the panel phoenix nmic/id-307, e.Coli was misidentified as citrobacter farmeri.There was no report of patient impact.

Manufacturer Narrative

The panel phoenix nmic/id-307 is an antimicrobial resistance panel that consists of a combination of the following 510k numbers: k020322, k023444, k023634, k023858, k024153, k031530, k031699, k032299, k032655, k033560, k041384, k042932, k052269, k060214, k060217, k060444, k060447, k060447, k061355, k062944, k063301, k063573, k063811, k063824, k071623, k132674, k151320 h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: this complaint is for misidentification of escherichia coli as citrobacter farmeri when using phoenix panel nmic/id-307 (catalog number 449289) batch number 3241425.The customer did not return isolates or panels but provided phoenix generated lab reports for the investigation.The customer provided phoenix lab reports show a patient isolate identified as c.Farmeri and e.Coli on the complaint batch.To investigate, two retention panels from complaint batch 3241425 were tested using in house isolate esbl positive e.Coli enf14299 on a phoenix m50 machine and evaluated for identification results.In addition, two control panels from the same material but different batch were tested using in house isolate esbl positive e.Coli enf14299 on a phoenix m50 machine and evaluated for identification results.Last, three control panels each from the same material but another different batch were tested using in house isolates esbl positive e.Coli enf15031 and esbl positive e.Coli enf14299 on a phoenix m50 machine and evaluated for identification results.Six of the ten panels identified the isolate as e.Coli, and the other 4 panels returned citrobacter spp.Or no id.Therefore, this complaint is confirmed for misidentification.As part of the investigation, bd r&d performed a biochemical analysis/comparison between the bd testing lab reports and the customer lab reports as well as a review of customer provided binary files.The customer submitted binary file confirmed variability in substrate reactions from those expected for e.Coli.A corrective and preventive action (capa) has been initiated for this issue.The technical team has identified a potential enhancement that would bolster the instrument¿s ability to interpret the behavior of e.Coli¿s interaction with the substrates on the panel.The batch history record was satisfactory, and no quality notifications were generated during manufacturing and inspection.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.H3 other text : see h.10.

Event Description

It was reported that during use with the panel phoenix nmic/id-307, e.Coli was misidentified as citrobacter farmeri.There was no report of patient impact.

• Brand Name: PANEL PHOENIX NMIC/ID-307
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18436721
• MDR Text Key: 331809255
• Report Number: 1119779-2023-01481
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 00382904492892
• UDI-Public: (01)00382904492892
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 449289
• Device Lot Number: 3241425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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