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	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter addr 1: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that with use of bd phoenix¿ smic/id-101 there was misidentification of strep a as strep b.There was no patient impact.The following information was provided by the initial reporter: there was misidentification of strep a as strep b.Hazard, injury or erroneous results details did erroneous results occur? y.If yes, detailed erroneous results (include # of errors and type): misidentification on smic panel.1.What result did the customer obtain from the bd product? strep b.2.What result was the customer expecting to obtain (if different from the obtained result) strep a.3.Was this a qc, validation, or proficiency test? n/a.4.Was patient treatment changed as a consequence of the issue with results? no.Result was release, but was caught early before patient care was affected.Corrected action was performed by the facility.5.Did the patient suffer any adverse medical consequences as a result of the change in treatment? n.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes, d9: returned to manufacturer on: 2023-06-21.H.6.Investigation summary: this complaint is for misidentification of strep a as strep b when using phoenix panel smic/id-101 (448802) batch number 2298178.The customer returned two panels, phoenix generated lab reports and two isolates for the investigation.The lab reports show an organism identified as s.Pyogenes group b and s.Pyogenes group a.The two customer returned isolates were tested on a bruker maldi for identification results.To investigate, one retention panel from the complaint batch 2298178 were tested using customer returned isolate s.Pyogenes 231601714 on a phoenix m50 machine and evaluated for identification results.Next, one retention panel from the complaint batch 2298178 were tested using customer returned isolate s.Pyogenes 231550715 on a phoenix m50 machine and evaluated for identification results.The bruker maldi identified customer returned isolates as s.Pyogenes.Both phoenix panels identified correctly as s.Pyogenes group a, 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 one additional complaint on the complaint batch, not related to this defect.Complaint trending was performed, and no trends were identified associated with this defect.
Event or Problem Description
It was reported that with use of bd phoenix¿ smic/id-101 there was misidentification of strep a as strep b.There was no patient impact.The following information was provided by the initial reporter: "there was misidentification of strep a as strep b.Hazard, injury or erroneous results details did erroneous results occur? y.If yes¿detailed erroneous results (include # of errors and type): misidentification on smic panel.1.What result did the customer obtain from the bd product? strep b.2.What result was the customer expecting to obtain (if different from the obtained result) strep a.3.Was this a qc, validation, or proficiency test? n/a.4.Was patient treatment changed as a consequence of the issue with results? no.Result was release, but was caught early before patient care was affected.Corrected action was performed by the facility.5.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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17195899
• Report Number: 1119779-2023-00700
• Device Sequence Number: 5642379
• Product Code: LON
• UDI-Device Identifier: 30382904488025
• UDI-Public: 30382904488025
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K051692
• 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): 07/26/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 06/24/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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