MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ PID; GRAM POSITIVE IDENTIFICATION PANEL

Model Number 448008

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

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

Event Date 10/23/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while testing with bd phoenix¿ pid a n incorrect result was obtained.An organism was identified as s.Epidermidis.Confirmatory testing was performed and the result was s.Aureus.There was no report of patient impact.The following information was provided by the initial reporter: result obtained from pid panel is s.Epidermidis, but characteristic of colony in blood agar plate not suitable and coagulase test positive.Customer re-identified by pid panels from same colony on (b)(6) 2021, still is s.Epidermidis.While other lab identified from that colony on (b)(6) 2021, use pid panel and maldi-top, obtains result is s.Aureus.

Manufacturer Narrative

H.6 investigation summary: this complaint is for mis id of staphylococcus aureus as staphylococcus epidermidis when using pid (b)(6) batch number 1048117.The customer did not provide isolates or returns but did provide specimen lab reports and binary files for the investigation.The complaint batch was not available for investigation due to the batch being expired at the time of the investigation.A review of quality notifications revealed no quality notifications generated on the complaint batches.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.Based on the investigation performed, this complaint is unable to be confirmed.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.Bd encourages you to consider the following parameters to optimize results within your laboratory.Qc testing should only be performed on 2nd pass subcultures and avoid using colonies that have been sub-cultured multiple times isolated colonies are to be used for inoculation and carefully check purity plates to ensure the inoculum consisted of one isolate type optimum performance comes from using fresh 18-24 hour, well-isolated colonies ensure proper, sufficient inoculum density allow bubbles to dissipate after vortexing properly calibrate the bd phoenixspec¿ nephelometer with in-date mcfarland calibration standards use swabs with minimal fiber shed make the proper inoculum density for the inoculum system setting (i.E., if preparing a 0.25 mcfarland inoculum, ensure that the system is set to 0.5 inoculum mode) volume of id broth should be visually assessed for any obvious low fills ensure proper incubation temperature and environment use the correct media type as listed as acceptable for use in the user¿s manual (note - it is helpful to disclose the media type and vendor when providing the details of the complaint) handle panels by only touching the sides; touching the front or back of the panels may cause interference in the readings and lead to errors follow user¿s manual instructions for time limits on pouring inoculated id broth into the panel and placing the panel into the instrument; extended periods of time outside of the stated limitations may yield errors.

Event Description

It was reported while testing with bd phoenix¿ pid a n incorrect result was obtained.An organism was identified as s.Epidermidis.Confirmatory testing was performed and the result was s.Aureus.There was no report of patient impact.The following information was provided by the initial reporter: result obtained from pid panel is s.Epidermidis, but characteristic of colony in blood agar plate not suitable and coagulase test positive.Customer re-identified by pid panels from same colony on (b)(6) oct 2021, still is s.Epidermidis.While other lab identified from that colony on (b)(6) oct 2021, use pid panel and maldi-top, obtains result is s.Aureus.

• Brand Name: BD PHOENIX¿ PID
• Type of Device: GRAM POSITIVE IDENTIFICATION PANEL
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12861827
• MDR Text Key: 281152787
• Report Number: 1119779-2021-01876
• Device Sequence Number: 1
• Product Code: LQL
• UDI-Device Identifier: 30382904480081
• UDI-Public: 30382904480081
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 448008
• Device Catalogue Number: 448008
• Device Lot Number: 1048117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• 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