MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ PMIC/ID-109; SEE H.10

Model Number	448609
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	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd phoenix¿ pmic/id-109 that there was discrepant results.The following information was provided by the initial reporter: customer reports discrepant results on antibiotic resistance.
Additional Manufacturer Narrative
Common device name: system, test, automated antimicrobial susceptibility, short incubation.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 false resistance for vancomycin (v) with staphylococcus epidermidis when using panel phoenix pmic/id-109 448609 batch 2152607.The customer provided one panel return, phoenix generated lab reports and log files for the investigation.The customer did not provide an isolate for the investigation.To investigate, the one (1) customer returned panel and four (4) retention panels from the complaint batch 2152607 were tested using qc isolate s.Epidermidis (pos3644) on a phoenix instrument and evaluated for vancomycin (v) mic results.For a total of five (5) panels tested.During investigation, all five panels tested yielded satisfactory mic results for qc isolate s.Epidermidis (pos3644) and vancomycin (v).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 no additional complaint on the complaint batch.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.H3 other text : see h.10.
Event or Problem Description
It was reported that while using the bd phoenix¿ pmic/id-109 that there was discrepant results.The following information was provided by the initial reporter: customer reports discrepant results on antibiotic resistance.

• Brand Name: BD PHOENIX¿ PMIC/ID-109
• Common Device Name: SEE H.10
• 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 ; 8015296192
• MDR Report Key: 16330838
• Report Number: 1119779-2023-00118
• Device Sequence Number: 6315097
• Product Code: LON
• UDI-Device Identifier: 30382904486090
• UDI-Public: 30382904486090
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K040716
• 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): 04/20/2023

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 Model Number: 448609
• Device Catalogue Number: 448609
• 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: 02/02/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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