MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX PANEL NMIC-306; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY

Catalog Number 449292

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

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

Event Date 11/26/2023

Event Type  malfunction  

Manufacturer Narrative

E:1.Initial reporter phone #: (b)(6).Bd phoenix nmic-306 is an antimicrobial resistance panel that consists of a combination of the following 510k numbers: g5.Pma / 510(k)#: k020322, k022129, k023444, k023634, k023858, k024153, k031530, k031699, k031912, k032299, k032567, k032655, k033362, k033560, k041384, k042932, k052269, k060214, k060217, k060257, k060444, k060447, k060447, k061327, k061355, k062207, k062944, k063301, k063486, k063573, k063811, k063824, k071623, k132674, k132909, k151320, k163637, k173252, k173523, k181665, k181665, k181665, k181665, k181665, k181665, k181665, k181665, k181665, k190905.H:3.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 when using the bd phoenix panel nmic-306 a patient isolate had a discrepant result for the drug meropenem when compared to the etest strip result.The panel result was sensitive while the etest was intermediate.No health impact or consequence reported.Report 1 of 2.

• Brand Name: BD PHOENIX PANEL NMIC-306
• 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: 18443159
• MDR Text Key: 332615362
• Report Number: 1119779-2023-01485
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 00382904492922
• UDI-Public: (01)00382904492922
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H.10
• 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
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 449292
• Device Lot Number: 3269849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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