MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ PMIC/ID-106; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number 448606

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

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

Event Date 02/21/2024

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 while testing with bd phoenix¿ pmic/id-106, s.Aureus was misidentified as s.Epidermidis.There was no health impact or consequences reported.

Manufacturer Narrative

H.6 investigation summary.This complaint is for misidentification of staphylococcus aureus as staphylococcus epidermidis when using phoenix panel pmic/id-106 (catalog number 448606) batch number 3192572.The customer did not return panels but provided isolates, phoenix generated lab reports and binary files for the investigation.To investigate, three retention panels each from the complaint batch were tested using customer returned isolates s.Aureus #1902 on a phoenix m50 machine and evaluated for identification results.Also, two control panels from the same material but different batch were tested using customer returned isolates s.Aureus #1902 on a phoenix m50 machine and evaluated for identification results.The five panels tested identified the isolate as s.Aureus, 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.The batch history record was satisfactory and no quality notifications were generated during manufacturing and inspection.A review of complaints revealed three additional complaints on the complaint batch, two of which are related to this defect and unconfirmed.Complaint trending was performed, and no trends were identified associated with this defect.Bd will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.

Event Description

It was reported while testing with bd phoenix¿ pmic/id-106, s.Aureus was misidentified as s.Epidermidis.There was no health impact or consequences reported.

• Brand Name: BD PHOENIX¿ PMIC/ID-106
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• 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: 18895264
• MDR Text Key: 337561589
• Report Number: 1119779-2024-00200
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382904486069
• UDI-Public: (01)30382904486069
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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: Other
• Device Catalogue Number: 448606
• Device Lot Number: 3192572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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