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

Model Number	448608
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	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported by the customer that they had misidentifications on bd phoenix¿ pmic/id-108.There was one occurrence in this event with patient involvement but patient treatment was not affected and there were no adverse events.The following information was provided by the customer: customer is reporting misidentification with panel 448608, lot 2048460.Patient identifier: (b)(6).
Additional Manufacturer Narrative
H.6 investigation summary.This complaint is not confirmed.This complaint is for misidentification of staphylococcus aureus as streptococcus agalactiae when using phoenix panel pmic/id 108 (448608) batch number 2048460.The customer did provide lab reports, but did not provide isolates or panels for investigation.To investigate, three retention panels from the complaint batch were tested on a phoenix m50 instrument using qc isolates of s.Aureus (a29213), and evaluated for identification results.During investigation, all panels identified correctly.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 complaints 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.Please continue to communicate any additional concerns.H3 other text : see h.10.
Event or Problem Description
It was reported by the customer that they had misidentifications on bd phoenix¿ pmic/id-108.There was one occurrence in this event with patient involvement but patient treatment was not affected and there were no adverse events.The following information was provided by the customer: "customer is reporting misidentification with panel 448608, lot 2048460.Patient identifier: (b)(6) ".

• Brand Name: BD PHOENIX¿ PMIC/ID-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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15529323
• Report Number: 1119779-2022-01261
• Device Sequence Number: 2533097
• Product Code: LON
• UDI-Device Identifier: 30382904486083
• UDI-Public: (01)30382904486083
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K033784
• 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): 01/12/2023

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: 02/28/2023
• Device Model Number: 448608
• Device Catalogue Number: 448608
• Device Lot Number: 2048460
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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