MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ PMIC/ID-107; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY

Catalog Number 448607

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

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

G5.Multiple 510k: k020322, k021954, k023273, k023301, k024152, k030677, k031306, k031679, k031679, k032131, k033784, k033907, k040006, k040106, k040716, k050089, k050555, k051689, k053241, k060214, k060217, k060218, k060493, k070809, k082538, k082852 h3.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 bd phoenix¿ pmic/id-107, staph auricularis was misidentified as corynebacterium jeikeium.There was no report of patient impact.

Event Description

It was reported that during use with the bd phoenix¿ pmic/id-107, staph auricularis was misidentified as corynebacterium jeikeium.There was no report of patient impact.

Manufacturer Narrative

The following fields were updated: d9.Device available for evaluation? yes.Returned to manufacturer on: 03-jan-2024.H6.Investigation summary: this complaint is for misidentification of staphylococcus auricularis as corynebacterium jekeium when using phoenix panel pmic/id-107 (catalog number 448607) batch number 3269790.The customer did not return isolates but provided phoenix generated lab reports, panels and binary files for the investigation.The customer provided phoenix lab reports show a patient isolate identified as c.Jekeium on the complaint batch.To investigate, three retention panels from complaint batch 3269790 were tested using in house isolate s.Auricularis pos165 on a phoenix m50 and evaluated for identification results.In addition, five control panels from the same material but different batch were tested using in house isolate s.Auricularis pos165 on a phoenix m50 and evaluated for identification results.Then, three customer returned panels from complaint batch 3269790 were tested using in house isolate s.Auricularis pos165 on a phoenix m50 and evaluated for identification results.The eleven panels tested identified the isolate as s.Auricularis, therefore, this complaint is not confirmed for misidentification.A review of the binary files was determined not to be required based on the results of the investigation.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed eight additional complaints on complaint batch 3269790, seven of which is related to this defect and unconfirmed.Of the seven related to this defect, four others are also from the customer.

• Brand Name: BD PHOENIX¿ PMIC/ID-107
• 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: 18435942
• MDR Text Key: 331795678
• Report Number: 1119779-2023-01468
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 00382904486075
• UDI-Public: (01)00382904486075
• 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: 01/31/2024

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: 448607
• Device Lot Number: 3269790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2023
• 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