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

Catalog Number	448607
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	07/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd phoenix¿ pmic/id-107, a patient sample was incorrectly identified.There was no report of patient impact.
Additional Manufacturer Narrative
G5.Multiple pma / 510(k)#: 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, and k131331.Investigation summary this complaint is for misidentification of methicillin resistant staphylococcus aureus as staphylococcus epidermidis when using phoenix panel pmic/id-107 (catalog number 448607) batch number 4008769.The customer provided panel returns, isolates, phoenix generated lab reports and binary files for the investigation.The lab reports show identifications of staphylococcus epidermidis when using the complaint batch.The isolates were verified on a bruker maldi biotyper and labeled as s.Aureus upmc-1, s.Aureus upmc-2, and s.Aureus upmc-3.Retention samples of complaint batch 4008769 were unavailable for testing and a comparable batch was used.To investigate, customer returned panels of the complaint batch were inoculated with customer returned isolates s.Aureus upmc-1, s.Aureus upmc-2, and s.Aureus upmc-3 and placed in a phoenix m50 to evaluate for identification results.Next, retention panels from the comparable batch and control panels were tested using customer returned isolates s.Aureus upmc-1, s.Aureus upmc-2, and s.Aureus upmc-3 and placed in a phoenix m50 to evaluate for identification results.Last, control panels from the same material but different batch were inoculated with methicillin resistant in house isolates s.Aureus pos 11872 and s.Aureus pos 11873 and placed in a phoenix m50 to evaluate for identification results.All panels (customer returned and retention) tested with the customer returned s.Aureus isolates (upmc-1, upmc-2, upmc-3) identified incorrectly as s.Epidermidis.The retention and control panels tested with in house s.Aureus isolates (pos 11872 and pos 11873) identified correctly as s.Aureus.This complaint is confirmed for misidentification of s.Aureus.This mdr is being submitted as part of a retrospective review of records dating april 2023-2025, under capa 11910483.

• Brand Name: BD PHOENIX¿ PMIC/ID-107
• Common Device Name: 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22952959
• Report Number: 1119779-2025-04895
• Device Sequence Number: 8260038
• Product Code: LON
• UDI-Device Identifier: 30382904486076
• UDI-Public: (01)30382904486076(11)240108(17)241226(10)4008769
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• 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
• Report Date (Section B): 07/10/2025

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: 12/26/2024
• Device Catalogue Number: 448607
• Device Lot Number: 4008769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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