MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ SMIC/ID-101; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	448802
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	09/22/2024
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)#: k032675, k050745, k050747, k050780, k050865, k050881, k050946, k050982, k051109, k051138, k051204, k051266, k051272, k051692, and k062206.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¿ smic/id-101 a patient isolate (streptococcus agalactiae) was misidentified as streptococcus constellatus.The user noted that the isolate was camp test positive.The user performed repeat testing.No health impact or consequence reported.
Event or Problem Description
It was reported while using the bd phoenix¿ smic/id-101 a patient isolate (streptococcus agalactiae) was misidentified as streptococcus constellatus.The user noted that the isolate was camp test positive.The user performed repeat testing.No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary this complaint is for misidentification of streptococcus agalactiae as streptococcus constellatus when using phoenix panel smic/id-101 (catalog number 448802) batch number 4044939.The customer did not return panels or isolates, but did provide binary files and phoenix generated lab reports for the investigation.Review of the lab reports show phoenix identifications of streptococcus constellatus when using the complaint batch.To investigate, retention panels from the complaint batch and a control panel from the same material but different batch number were tested using in house streptococcus agalactiae isolates on a phoenix m50 machine and evaluated for identification results.All panels tested identified the isolates as streptococcus agalactiae, 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.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.Bd encourages you to consider the following parameters to optimize results within your laboratory.Qc testing should only be performed on 2nd pass subcultures and avoid using colonies that have been sub-cultured multiple times isolated colonies are to be used for inoculation and carefully check purity plates to ensure the inoculum consisted of one isolate type optimum performance comes from using fresh 18-24 hour, well-isolated colonies ensure proper, sufficient inoculum density allow bubbles to dissipate after vortexing properly calibrate the bd phoenixspec¿ nephelometer with in-date mcfarland calibration standards use swabs with minimal fiber shed make the proper inoculum density for the inoculum system setting (i.E., if preparing a 0.5 mcfarland inoculum, ensure that the system is set to 0.5 inoculum mode) volume of id broth should be visually assessed for any obvious low fills ensure proper incubation temperature and environment use the correct media type as listed as acceptable for use in the user¿s manual (note - it is helpful to disclose the media type and vendor when providing the details of the complaint) handle panels by only touching the sides; touching the front or back of the panels may cause interference in the readings and lead to errors follow user¿s manual instructions for time limits on pouring inoculated id broth into the panel and placing the panel into the instrument; extended periods of time outside of the stated limitations may yield errors.

• Brand Name: BD PHOENIX¿ SMIC/ID-101
• 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: 20612047
• Report Number: 1119779-2024-00809
• Device Sequence Number: 7411347
• Product Code: LON
• UDI-Device Identifier: 30382904488025
• UDI-Public: (01)30382904488025(11)240213(17)250210(10)4044939
• 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): 02/04/2025

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: 02/10/2025
• Device Catalogue Number: 448802
• Device Lot Number: 4044939
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• 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