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

Catalog Number	449452
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g4.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, k061327, k061355 ,k062207 ,k062944, k063301, k063486, k063573, k063811, k063824, k071623, k123404, k132674, k132909, k151320 ,k173252 ,k190905, k163637 ,k173523 k033458 and k123266.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using the bd phoenix¿ nmic-311 a patient isolate (escherichia coli) had a high mic (false resistance) for the drug imipenem but when repeated it was sensitive.The user also noted that the drug ertapenem periodically gave high mics.No health impact or consequence reported.Report 2 of 2.
Additional Manufacturer Narrative
Investigation summary this complaint is for false positive cpo when using phoenix panel nmic-311 (catalog number 449452) batch number 4254980.The customer did not return panels or phoenix generated lab reports but provided isolates and a photo of the phoenix epicenter for the investigation.The lab reports show the test sequence of the panels.To investigate, retention panels of the complaint batch and control panels were tested using customer returned isolates escherichia coli 6765 and klebsiella pneumoniae 4629 on a phoenix m50 machine and evaluated for carbapenem mic results and cpo flags.All panels tested returned the expected mics and cpo negative flags, this complaint is not confirmed.The batch history record was satisfactory and no quality notifications were generated during manufacturing and inspection.Complaint trending was performed and no trends were identified associated with this defect.Bd will continue to monitor for trends and take action as necessary.Please continue to communicate any additional concerns.
Event or Problem Description
It was reported while using the bd phoenix¿ nmic-311 a patient isolate (escherichia coli) had a high mic (false resistance) for the drug imipenem but when repeated it was sensitive.The user also noted that the drug ertapenem periodically gave high mics.No health impact or consequence reported.Report 2 of 2.

• Brand Name: BD PHOENIX¿ NMIC-311
• Common Device Name: 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20925385
• Report Number: 1119779-2024-00987
• Device Sequence Number: 14719596
• Product Code: LON
• UDI-Device Identifier: 30382904494521
• UDI-Public: (01)30382904494521(11)240910(17)250913(10)4254980
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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
• Operator of Device: Other
• Device Expiration Date: 09/13/2025
• Device Catalogue Number: 449452
• Device Lot Number: 4254980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown