MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD 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 11/30/2021

Event Type  malfunction  

Manufacturer Narrative

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 while using bd panel phoenix nmic/id-307 a misidentification was observed by the laboratory personnel.A repeat test was used to confirm the results.The customer stated that results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that there was an isolate that the phoenix called shigella.The isolate was repeated and then they got an id of e.Coli.".

Manufacturer Narrative

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 while using bd panel phoenix nmic/id-307 a misidentification was observed by the laboratory personnel.A repeat test was used to confirm the results.The customer stated that results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that there was an isolate that the phoenix called shigella.The isolate was repeated and then they got an id of e.Coli.".

Manufacturer Narrative

H.6 investigation summary this complaint is not confirmed.This complaint is for misidentification of escherichia coli as shingella when using phoenix panel nmic/id-307 (449289) batch number 1208671.The customer did return lab reports, but did not return isolates or panels for investigation.To investigate, a total of 6 retention panels from the complaint batch were tested on a phoenix instrument, where three panels were tested using qc isolate atcc 25922 of escherichia coli and three panels were tested using qc isolate atcc 35218 of escherichia coli, 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 two 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.Per baltrmphxidastaph rev 10 version h, id 6.0-6.11, indicates the potential risk of a misidentification was assessed as s4.

Event Description

It was reported that while using bd panel phoenix nmic/id-307 a misidentification was observed by the laboratory personnel.A repeat test was used to confirm the results.The customer stated that results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that there was an isolate that the phoenix called shigella.The isolate was repeated and then they got an id of e.Coli.".

• Brand Name: BD 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13081710
• MDR Text Key: 285756227
• Report Number: 1119779-2021-02033
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Model Number: 449289
• Device Catalogue Number: 449289
• Device Lot Number: 1208671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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