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

Model 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	05/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Report 2 of 2 it was reported that during use with the bd phoenix¿ smic/id-101 panel, strep viridans was misidentified as group b strep.There was no report of patient impact.The following information was provided by the initial reporter: customer reports organism misidentifications 1.What result did the customer obtain from the bd product? isolate 2 - strep viridans identified as group b strep.2.What result was the customer expecting to obtain (if different from the obtained result)? isolate 2 was not noted if any repeat was performed.3.Was this a qc, validation, or proficiency test? patient isolates 4.Was patient treatment changed as a consequence of the issue with results? no 5.Did the patient suffer any adverse medical consequences as a result of the change in treatment? no.
Additional Manufacturer Narrative
G5.510k #: the bd phoenix¿ smic/id-101 is an antimicrobial resistance panel that consists of a combination of the following 510k numbers: k050745, k050747, k050780, k050865, k050881, k050946, k050982, k051109, k051138, k051204, k051266, k051272, k051692, k062206.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
This complaint is for misidentification of strep viridans as group b strep or lactococcus when using phoenix panel smic/id-101 (448802) batch number 2298178.The customer provided phoenix generated lab reports but did not provide panel returns or isolates for the investigation.The customer noted that the patient isolates were taken from remel chocolate agar.To investigate, five (5) retention panels from complaint batch 2298178 were tested using in house isolate with the expected result of s.Mitis (pos 1846) on a phoenix m50 instrument and evaluated for identification results.During the investigation, three (3) of the panels identified as s.Mitis group, one (1) panel identified as s.Mitis and one (1) panel returned no id.Note the s.Mitis group includes s.Mitis.S.Mitis group also belong to the s.Viridians group.Therefore, this complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed two additional complaints on the complaint batch, not related to this defect.Complaint trending was performed, and no trends were identified associated with this defect across this panel sku (#448802).Bd id/ast plant quality will continue to monitor mis ids for trends and take action as necessary.Please continue to communicate any additional concerns.H3 other text : see h.10.
Event or Problem Description
Report 2 of 2.It was reported that during use with the bd phoenix¿ smic/id-101 panel, strep viridans was misidentified as group b strep.There was no report of patient impact.The following information was provided by the initial reporter: customer reports organism misidentifications.What result did the customer obtain from the bd product? isolate 2 - strep viridans identified as group b strep.What result was the customer expecting to obtain (if different from the obtained result)? isolate 2 was not noted if any repeat was performed.Was this a qc, validation, or proficiency test? patient isolates was patient treatment changed as a consequence of the issue with results? no did the patient suffer any adverse medical consequences as a result of the change in treatment? no.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17138270
• Report Number: 1119779-2023-00668
• Device Sequence Number: 3893127
• Product Code: LON
• UDI-Device Identifier: 30382904488025
• UDI-Public: 30382904488025
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2023

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: 10/23/2023
• Device Model Number: 448802
• Device Catalogue Number: 448802
• Device Lot Number: 2298178
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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