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

Model Number 449289

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

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

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot#: 2285390.Medical device expiration date: 03-oct-2023.Device manufacture date: 12-oct-2022.Medical device lot#: 2249522.Medical device expiration date: 30-sep-2023.Device manufacture date: 06-sep-2022.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that panel phoenix nmic/id-307 misidentification has occurred for patient samples.The following information was provided by the initial reporter: customer confirms this issue has been occurring on and off since (b)(6) 2022, and with both patient and qc samples.

Event Description

It was reported that panel phoenix nmic/id-307 misidentification has occurred for patient samples.The following information was provided by the initial reporter: customer confirms this issue has been occurring on and off since november of 2022, and with both patient and qc samples.

Manufacturer Narrative

H.6 investigation summary: this complaint is not confirmed.This complaint is for mis-identification of e.Coli atcc 35218 when using phoenix panel nmic/id-307 (449289) batch numbers 2285390 and 2249522.The customer did not provide lab reports but provided isolates and panel returns of batch 2285390 for the investigation.To investigate, five (5) retention samples of complaint batch 2285390 were inoculated with qc isolate e.Coli a35218 and evaluated in a phoenix m50 for identification results.Next, one (1) retention sample of complaint batch 2249522 were inoculated with qc isolate e.Coli a35218 and evaluated in a phoenix m50 for identification results.Then, one (1) customer returned panel of complaint batch 2285390 were inoculated with qc sample p.Aeruginosa 1a-1 and evaluated in a phoenix m50 for identification results.In addition, one (1) customer returned panel of complaint batch 2285390 were inoculated with qc sample p.Aeruginosa 1a-2 and evaluated in a phoenix m50 for identification results.Then, one (1) retention panel of complaint batch 2249522 were inoculated with qc sample p.Aeruginosa 1b-1 and evaluated in a phoenix m50 for identification results.Last, one (1) retention panel of complaint batch 2249522 were inoculated with qc sample p.Aeruginosa 1b-2 and evaluated in a phoenix m50 for identification results.All ten (10) panels identified their respective isolates accurately, therefore this complaint is not confirmed.A review of quality notifications revealed no quality notifications for the complaint batches.A review of complaints revealed one (1) additional complaint on complaint batch 2285390, which is related to this defect and no complaints on batch 2249522.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.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.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16439915
• MDR Text Key: 310354024
• Report Number: 1119779-2023-00179
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382904492893
• UDI-Public: 30382904492893
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 449289
• Device Catalogue Number: 449289
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1