MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PANEL PHOENIX NMIC-311; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY

Catalog Number 449452

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

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

Event Date 01/07/2024

Event Type  malfunction  

Event Description

It was reported when using the bd panel phoenix nmic-311 a patient blood isolate had a high mic for the drugs meropenem and ertapenem when compared to the vitek 2 instrumentation and kirby bauer (kb) disk result.No health impact or consequence reported.Report 1 of 2.

Manufacturer Narrative

G.5.Pma/510(k)#: the panel phoenix nmic/id-311 is an antimicrobial resistance panel that consists of a combination of the following 510k numbers: k032299, k061355, k061327, k031912, k023444, k063824, k033560, k063573, k041384, k060217, k052269, k190905, k032655, k062944, k060444, k173252, k033362, k062207, k063811, k163637, k151320, k063301, k031530, k060447, k032567, k060257, k023634, k123404, k020322, k132674, k173523, k063486, k022129, k023858, k071623, k031699, k060447, k024153, k060214, k132909, k042932 h.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD PANEL PHOENIX NMIC-311
• 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: 18639813
• MDR Text Key: 334535283
• Report Number: 1119779-2024-00071
• Device Sequence Number: 1
• Product Code: LON
• 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
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 449452
• Device Lot Number: 3304066
• 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: 10/31/2023
• 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