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

Model Number 449289

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

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

Event Date 11/18/2021

Event Type  malfunction  

Manufacturer Narrative

The bd phoenix nmic-307 is an antimicrobial resistance panel that consists of a combination of the following 510k numbers: k032299, k061355, k023444, k063824, k033560, k063573, k041384, k060217, k052269, k032655, k062944, k060444, k063811, k151320, k063301, k031530, k060447, k023634, k020322, k132674, k023858, k071623, k031699, k060447, k024153, k060214, k042932.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 that while testing with panel phoenix nmic/id-307, a specimen was identified incorrectly.There was no report of patient impact.The following information was provided by the initial reporter: reported an organism was misidentified.

Event Description

It was reported that while testing with panel phoenix nmic/id-307, a specimen was identified incorrectly.There was no report of patient impact.The following information was provided by the initial reporter: reported an organism was misidentified.

Manufacturer Narrative

H.6 investigation summary: this complaint is for misidentification of e.Cloacae when using phoenix panel nmic/id-307 (449289) batch number 1251384.The customer did provide lab reports, but did not provide isolates or panels for investigation.To investigate, three retention panels from the complaint batch were tested on a phoenix m50 instrument using qc isolates of enterobacter cloacae (11061), 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.H3 other text : see h.10.

• Brand Name: PANEL PHOENIX NMIC/ID-307
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13119280
• MDR Text Key: 287585915
• Report Number: 1119779-2021-02064
• 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: SEE H10
• 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: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Model Number: 449289
• Device Catalogue Number: 449289
• Device Lot Number: 1251384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• 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