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

Catalog Number	448606
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with the bd phoenix¿ pmic/id-106, s.Pettenkoferi was misidentified as corynebacterium jeikeium.There was no report of patient impact.
Additional Manufacturer Narrative
G.5.Pma / 510k number: the bd phoenix pmic/id-106 is an antimicrobial resistance panel which consists of a combination of the following 510k numbers: k131331, k020322, k021954, k022172, k023273, k023301, k024152, k030677, k031306, k031679, k032131, k033784, k033907, k040006, k040106, k040716, k050555, k051689, k053241, k060214, k060217, k060218, k060493, k082538, k082852, k082913 h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: this complaint is for misidentification when using phoenix panel pmic/id-106 (catalog number 448606) batch number 3150521.The customer returned phoenix generated lab reports, isolates and binary files but did not return panels for the investigation.The customer returned lab reports show patient samples of corynebacterium jeikeium as staphylococcus pettenkoferi.The customer returned isolates were verified on a bruker maldi biotyper and labeled as s.Pettenkoferi n-13 and e.Faecalis n-14.To investigate, two retention panels of the complaint batch were tested using customer returned isolates s.Pettenkoferi n-13 and e.Faecalis n-14 on a phoenix m50 machine and evaluated for identification results.Then, one control panel from the same material but different batch were inoculated with customer returned isolate e.Faecalis n-14 on a phoenix m50 machine and evaluated for identification results.Last, two control panels from the same material but different batch were inoculated with customer returned isolate s.Pettenkoferi n-13 on a phoenix m50 machine and evaluated for identification results.All seven panels identified their inoculated isolate correctly , 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 no additional confirmed complaints on complaint batch 3150521.Complaint trending was performed, and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.
Event or Problem Description
It was reported that during use with the bd phoenix¿ pmic/id-106, s.Pettenkoferi was misidentified as corynebacterium jeikeium.There was no report of patient impact.

• Brand Name: BD PHOENIX¿ PMIC/ID-106
• Common Device Name: 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: 18420404
• Report Number: 1119779-2023-01446
• Device Sequence Number: 7965100
• Product Code: LON
• UDI-Device Identifier: 30382904486069
• UDI-Public: (01)30382904486069
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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
• Operator of Device: Other
• Device Expiration Date: 05/22/2024
• Device Catalogue Number: 448606
• Device Lot Number: 3150521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown