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

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	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd phoenix¿ pmic/id-107 a patient isolate (staphylococcus aureus) was misidentified as group b strep (gbs) or streptococcus agalactiae.The user verified the final result using catalase and coagulase.The user also noted performing repeat testing and that the isolate was coagulase positive and beta hemolytic.No health impact or consequence reported.This is report 3 of 4.
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g4.Pma /510(k)#: k020322, k021954, k023273, k023301, k024152, k030677, k031306, k031679, k032131, k033784, k033907, k040006 ,k040106, k040716, k050089, k050555, k051689, k053241, k060214, k060217, k060218, k060493, k070809, 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-107 a patient isolate (staphylococcus aureus) was misidentified as group b strep (gbs) or streptococcus agalactiae.The user verified the final result using catalase and coagulase.The user also noted performing repeat testing and that the isolate was coagulase positive and beta hemolytic.No health impact or consequence reported.This is report 3 of 4.
Additional Manufacturer Narrative
Investigation summary: this complaint is for misidentification of staphylococcus aureus as streptococcus group b when using phoenix panel pmic/id-107 (catalog number 448607) batch number 5189208.The customer returned phoenix generated lab reports and an isolate for the investigation.The customer returned isolate was verified and labeled as s.Aureus with a bruker maldi biotyper.To investigate, panels of the complaint batch and control panels from the same material but different batch were tested using in house and customer returned isolates s.Aureus 3605 and s.Aureus a29213 on a phoenix m50 machine and evaluated for identification results.The panels inoculated with in house isolate s.Aureus a29213 tested identified their inoculated isolate correctly.The panels tested with customer returned isolate s.Aureus 3605 identified the isolate as streptococcus agalactiae (streptococcus group b), therefore this complaint is 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.Please continue to communicate any additional concerns.

• Brand Name: BD PHOENIX¿ PMIC/ID-107
• 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 ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 24236301
• Report Number: 1119779-2026-00034
• Device Sequence Number: 15696053
• Product Code: LON
• UDI-Device Identifier: 30382904486076
• UDI-Public: (01)30382904486076(17)260702(10)5189208
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/06/2026

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: 07/02/2026
• Device Catalogue Number: 448607
• Device Lot Number: 5189208
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2025
• 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