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	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd phoenix¿ smic/id-101 there was misidentification.The following was reported by the initial reporter: specimen lab report and binary file has been added to (b)(4).Were this patient samples? if so, what results were reported? the discrepancies were all patient samples.I believe most of the incorrect id's were caught before reporting them out but it is very easy for them to slip by when you're dealing with large numbers of results.Was patient treatment affected and were there any adverse events? n/a.Customer is reporting misidentification of strep anginosus.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6.Investigation summary: this complaint is for misidentification of streptococcus anginosus when using phoenix panel smic/id-101 (catalog number 448802) batch number 3024084.The customer did not return panels but provided isolates, binary files and phoenix generated lab reports for the investigation.The lab reports show a patient sample identified as s.Anginosus when using the complaint batch.The customer returned isolate did not grow and was not viable for complaint investigation testing.Upon subsequent follow ups, the customer stated that they will not send a new isolate for investigation testing.To investigate, two retention panels each from complaint batch 3024084 were tested using qc isolate s.Anginosus pos 3603 and pos 9984 on a phoenix m50 machine and evaluated for identification results.Next, two control panels each from the same material but different batch were tested using qc isolate s.Anginosus pos 3603 and pos 9984 on a phoenix m50 machine and evaluated for identification results.All eight panels identified as s.Anginosus, 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.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed five other complaints on batch 3024084, not related to this defect.Complaint trending was performed and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.
Event or Problem Description
It was reported that while using bd phoenix¿ smic/id-101 there was misidentification.The following was reported by the initial reporter: specimen lab report and binary file has been added to q:\bd phoenix m50 accounts\(b)(6).Were this patient samples? if so, what results were reported? the discrepancies were all patient samples.I believe most of the incorrect id's were caught before reporting them out but it is very easy for them to slip by when you're dealing with large numbers of results.Was patient treatment affected and were there any adverse events? n/a.Customer is reporting misidentification of strep anginosus.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17936019
• Report Number: 1119779-2023-01125
• Device Sequence Number: 6401001
• Product Code: LON
• UDI-Device Identifier: 30382904488025
• UDI-Public: 30382904488025
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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: 01/16/2024
• Device Catalogue Number: 448802
• Device Lot Number: 3024084
• 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: 09/19/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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