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

Catalog Number	448416
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	07/28/2025
Type of Reportable Event	Malfunction
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, k022172, k023273, k023301, k024152, k030677, k031306, k031679, k032131, k033784, k033907, k040006, k040106, k040716, k050555, k051689, k053241, k060214, k060217, k060218, k060493, k082538, k082852, k082913, 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-106 a patient blood culture isolate methicillin-resistant staphylococcus aureus (mrsa) was misidentified as methicillin-susceptible staphylococcus aureus (mssa).The user noted the isolate's final result was verified using pcr and disc diffusion and repeat testing.No health impact or consequence reported.Report 1 of 2.
Additional Manufacturer Narrative
Investigation summary: this complaint is for low mic results with staphylococcus aureus when using phoenix panel pmic-106 (catalog number 448416) batch number 5070846.The customer returned isolates and phoenix generated lab reports for the investigation.Cefoxitin (fox) was also investigated as a surrogate test for this investigation.To investigate, retention panels of the complaint batch were tested using customer returned and in house isolates s.Aureus a43300, s.Aureus 15-a, s.Aureus 15-n, s.Aureus 16-a and s.Aureus 16-n on a phoenix m50 machine and evaluated for ox and fox mic results.The panels tested with qc isolate s.Aureus a43300 returned the expected mic results for fox and ox.The panels tested with customer returned isolates returned susceptible mic results.For additional testing, disk diffusion testing was performed on customer returned isolates s.Aureus 15-a, s.Aureus 15-n, s.Aureus 16-a and s.Aureus 16-n.Also, customer returned isolates s.Aureus 15-a, s.Aureus 15-n, s.Aureus 16-a and s.Aureus 16-n were placed in another gram positive control panel to observe for presence of beta-lactamase.The disk diffusion results show all isolates with resistance to fox.The ncf screen returned rule 1506 flags detecting beta-lactamase.As a result of the phoenix panel testing and disk diffusion testing, 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.As no trends were identified, no corrective actions are slated at this time.Bd will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.
Event or Problem Description
It was reported while using the bd phoenix¿ pmic-106 a patient blood culture isolate methicillin-resistant staphylococcus aureus (mrsa) was misidentified as methicillin-susceptible staphylococcus aureus (mssa).The user noted the isolate's final result was verified using pcr and disc diffusion and repeat testing.No health impact or consequence reported.Report 1 of 2.

• Brand Name: BD PHOENIX¿ PMIC-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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 22925924
• Report Number: 1119779-2025-04642
• Device Sequence Number: 9162739
• Product Code: LON
• UDI-Device Identifier: 30382904484164
• UDI-Public: (01)30382904484164(17)260311(10)5070846
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/05/2026

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: 03/11/2026
• Device Catalogue Number: 448416
• Device Lot Number: 5070846
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• 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