MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ PMIC/ID-109; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	448609
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	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone #: (b)(6).There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g4.Pma / 510(k)#: k020322, k021954, k022172, k023273, k023301, k023568, k024152, k030677, k031306, k031679, k031679, k032131, k033784, k033907, k040006, k040106, k040716, k050089, k051689, k053241, k060214, k060217, k060218, k060218, k060493, k082538, k082852, and k131331.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using the bd phoenix¿ pmic/id-109 a patient isolate s.Aureus was misidentified as s.Epidermidis, the user noted that a corrected reported was made to the provider.No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: this complaint is for misidentification of staphylococcus aureus as staphylococcus epidermidis when using phoenix panel pmic/id-109 (catalog number 448609) batch number 4123688.The customer did not return panels or isolates but provided phoenix generated lab reports for the investigation.The lab reports show s.Aureus and s.Epidermidis identifications when using the complaint batch.To investigate, retention panels of the complaint batch were tested using qc isolates s.Aureus a29213 and s.Aureus a25923 on a phoenix m50 machine and evaluated for identification results.In addition, one control panel from the same material but different batch were tested using qc isolate s.Aureus a29213 on a phoenix m50 machine and evaluated for identification results.The panels tested identified their inoculated isolates as s.Aureus.This complaint is not confirmed.The batch history record was satisfactory and no quality notifications were generated during manufacturing and inspection.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.
Event or Problem Description
It was reported while using the bd phoenix¿ pmic/id-109 a patient isolate s.Aureus was misidentified as s.Epidermidis, the user noted that a corrected reported was made to the provider.No health impact or consequence reported.

• Brand Name: BD PHOENIX¿ PMIC/ID-109
• 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: matt j. connor_old ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20792024
• Report Number: 1119779-2024-00933
• Device Sequence Number: 15161693
• Product Code: LON
• UDI-Device Identifier: 30382904486090
• UDI-Public: (01)30382904486090(11)240502(17)250425(10)4123688
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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: 04/25/2024
• Device Catalogue Number: 448609
• Device Lot Number: 4123688
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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