MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ PMIC-108; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	448418
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	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the bd phoenix¿ pmic-108 an unspecified number of patient samples have a high mic for the drug vancomycin for the isolate staphylococcus aureus.One erroneous patient result was reported.There was no patient treatment change as a result.Confirmatory testing performed on the microscan, where the isolate was not resistant.
Additional Manufacturer Narrative
The information for the additional 510k is as follows: g5.Pma / 510(k)#: k020322, k021954, k022172, k023273, k023301, k024152, k030677, k031306, k031589, k031679, k032131, k033784, k033907, k040006, k040106, k040716, k050555, k051689, k053241, k060214, k060217, k060218, k060493, k070809, k082538, k082852, and k131331.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
Investigation summary: this complaint is for high mic vancomycin (va) with staphylococcus aureus when using phoenix panel pmic-108 (catalog number 448418) batch number 3332901.The customer did not provide isolates, panel returns or phoenix generated lab reports for the investigation.To investigate, three retention panels from the complaint batch were inoculated with in house isolate s.Aureus 7146 then placed in a phoenix m50 for va mic results.In addition, one control panels from the same material but different batch were inoculated with in house isolate s.Aureus 7146 then placed in a phoenix m50 for va mic results.Results of the investigation returned all panels with the expected mic for va.This complaint is not 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.Bd will continue to monitor for trends and take action as necessary.
Event or Problem Description
It was reported while using the bd phoenix¿ pmic-108 an unspecified number of patient samples have a high mic for the drug vancomycin for the isolate staphylococcus aureus.One erroneous patient result was reported.There was no patient treatment change as a result.Confirmatory testing performed on the microscan, where the isolate was not resistant.

• Brand Name: BD PHOENIX¿ PMIC-108
• 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: 19826703
• Report Number: 1119779-2024-00565
• Device Sequence Number: 8891984
• Product Code: LON
• UDI-Device Identifier: 30382904484188
• UDI-Public: (01)30382904484188
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• 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): 10/25/2024

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: 11/19/2024
• Device Catalogue Number: 448418
• Device Lot Number: 3332901
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2023
• 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