MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ PMIC-107; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number 448607

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  Injury  

Event Description

It was reported that during use with the bd phoenix¿ pmic-107, there were false patient results.Staph aureus was incorrectly identified as vancomycin resistant.The patient was given incorrect treatment based on this result.

Manufacturer Narrative

G5.Multiple 510(k): k020322, k021954, k023273, k023301, k024152, k030677, k031306, k031679, k031679, k032131, k033784, k033907, k040006, k040106, k040716, k050089, k050555, k051689, k053241, k060214, k060217, k060218, k060493, k070809, k082538, k082852.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following information has been updated with corrected and/or additional information: d9: device available for eval? yes.D9: returned to manufacturer on: 04-apr-2024.H6: investigation summary: this complaint is for false resistance of staphylococcus aureus as vancomycin (va) resistant mrsa when using phoenix panel pmic/id-107 (catalog number 448607) batch number 4008769.The customer returned panels, isolates and phoenix generated lab reports for the investigation.The lab reports show patient samples identified as staphylococcus aureus and vancomycin resistant mrsa with the complaint batch.To investigate, three retention panels from complaint batch 4008769 were tested using customer returned isolate s.Aureus (sa) on a phoenix m50 machine and evaluated for methicillin resistance results.Next, three customer returned panels from complaint batch 4008769 were tested using customer returned isolate s.Aureus (sa) on a phoenix m50 machine and evaluated for methicillin resistance results.Last, one control panel from the same material but different batch was tested using customer returned isolate s.Aureus (sa) on a phoenix m50 machine and evaluated for methicillin resistance results.All panels identified their isolate as s.Aureus with low mic result for va, therefore, this complaint is not confirmed for false resistance.The batch history record was satisfactory and no quality notifications were generated during manufacturing and inspection.A review of complaints revealed no additional complaints on complaint batch 4008769.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 Description

It was reported that during use with the bd phoenix¿ pmic-107, there were false patient results.Staph aureus was incorrectly identified as vancomycin resistant.The patient was given incorrect treatment based on this result.

• Brand Name: BD PHOENIX¿ PMIC-107
• Type of Device: 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: 18967515
• MDR Text Key: 338470051
• Report Number: 1119779-2024-00220
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382904486076
• UDI-Public: (01)30382904486076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 448607
• Device Lot Number: 4008769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other