MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PANEL PHOENIX NMIC/ID-307; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY

Catalog Number 449289

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

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

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

Bd phoenix nmic/id-307 is an antimicrobial resistance panel that consists of a combination of the following 510k numbers: g5.Pma / 510(k)#: k020322, k023444, k023634, k023858, k024153, k031530, k031699, k032299, k032655, k033560, k041384, k042932, k052269, k060214, k060217, k060444, k060447, k060447, k061355, k062944, k063301, k063573, k063811, k063824, k071623, k132674, k151320.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

Report 1 of 3.It was reported that during use of the panel phoenix nmic/id-307, there was a mis-id.No patient impact was reported.Patient #1: 1st run was on (b)(6) 2023, id = e.Coli repeat was on (b)(6) 2023, id = citrobacter braakii specimen was run on vitek on (b)(6), id = salmonella enterocolitica sent to public health lab for final id, finalized as salmonella spp.On (b)(6) customer subbed the isolate to hektoen enteric agar - isolate was an h2s producer only salmonella spp.Was reported.

Event Description

Report 1 of 3.It was reported that during use of the panel phoenix nmic/id-307, there was a mis-id.No patient impact was reported.Patient #1: 1st run was on (b)(6) 2023, id = e.Coli.Repeat was on (b)(6) 2023, id = citrobacter braakii.Specimen was run on vitek on (b)(6), id = salmonella enterocolitica.Sent to public health lab for final id, finalized as salmonella spp.On (b)(6).Customer subbed the isolate to hektoen enteric agar - isolate was an h2s producer only salmonella spp.Was reported.

Manufacturer Narrative

H6.Investigation summary: this complaint is for misidentification when using phoenix panel nmic/id-307 (catalog number 449289) batch number 3241315.The customer did not return panels but provided phoenix generated lab reports, isolates and binary files for the investigation.The customer provided phoenix lab reports show a misidentifications of proteus mirabilis as providencia rettgeri and salmonella species as escherichia coli when using the complaint batch.To investigate, two retention panels each from the complaint batch were tested using customer returned isolates p.Mirabilis 1385, p.Mirabilis 1281 and s.Enterocolitica 1422 on a phoenix m50 machine and evaluated for identification results.In addition, one control panel each from the same material but different batch were tested using customer returned isolates p.Mirabilis 1385, p.Mirabilis 1281 and s.Enterocolitica 1422 on a phoenix m50 machine and evaluated for identification results.All eight panels tested identified their isolate correctly, therefore, this complaint is not confirmed for misidentification.A review of the binary files was determined not to be required based on the results of the investigation.The batch history record was satisfactory and no quality notifications were generated during manufacturing and inspection.A review of complaints revealed six additional complaints on the complaint batch, four of which are related to this defect and unconfirmed.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.

• Brand Name: PANEL PHOENIX NMIC/ID-307
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY
• 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: 18655288
• MDR Text Key: 336076826
• Report Number: 1119779-2024-00082
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 449289
• Device Lot Number: 3241315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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