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 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

Bd phoenix nmic-311 is an antimicrobial resistance panel that consists of a combination of the following 510k numbers: g.5.Pma / 510(k)#: 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.

Event Description

Report 2 of 4.It was reported when using the bd panel phoenix nmic-311, a false resistant ertapenem antibiotic result was obtained on a patient.The customer re-tested using an etest and a sensitive ertapenem antibiotic result was obtained.There was no report of patient impact.

• 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: 18635085
• MDR Text Key: 335417423
• Report Number: 1119779-2024-00066
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 00382904494520
• UDI-Public: (01)00382904494520
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 449452
• Device Lot Number: 3241572
• 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: 08/29/2023
• 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