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

Catalog Number	449289
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	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the panel phoenix nmic/id-307 a patient isolate (proteus mirabilis) was misidentified as escherichia coli.No health impact or consequence reported.This is report 2 of 2.
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)#: g4.Pma / 510(k)# k020322, k023444, k023634, k023858, k024153, k031530, k031699, k032299, k032655, k033560, k041384, k042932, k052269, k060214, k060217, k060444, k060447, k061355, k062944, k063301, k063573, k063811, k063824, k071623, k132674, k151320, k181665, 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.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.D10.Device available for eval- yes.D10.Returned to manufacturer on 01-apr-2026.H3.Device eval by manufacturer- yes.Investigation summary: this complaint is for misidentification of proteus when using phoenix panel nmic/id-307 (catalog number 449289) batch number 5324454.The customer returned a phoenix generated lab report, an isolate and panel returns for the investigation.The lab report shows identifications of escherichia coli when using the complaint batch.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.To investigate, customer returned panels, retention panels of the complaint batch and control panels from the same material but different batch were tested using customer returned isolate proteus mirabilis on a phoenix m50 machine and evaluated for identification results.The panels tested identified their inoculated isolate correctly, this complaint is unable to be confirmed.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 panel phoenix nmic/id-307 a patient isolate (proteus mirabilis) was misidentified as escherichia coli.No health impact or consequence reported.This is report 2 of 2.

• Brand Name: PANEL PHOENIX NMIC/ID-307
• 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: 24778225
• Report Number: 1119779-2026-00607
• Device Sequence Number: 6064295
• Product Code: LON
• UDI-Device Identifier: 30382904492893
• UDI-Public: (01)30382904492893(17)261112(10)5324454
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/18/2026

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 Catalogue Number: 449289
• Device Lot Number: 5324454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2025
• 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