MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) PANEL PHOENIX PMIC-110; SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	449036
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	01/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone #: (b)(6).There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g4.Pma / 510(k)#: k020322, k021954, k022172, k023273, k023301, k023568, k024152, k030091, k030677, k031306, k031679, k032131, k033784, k033889, k033907, k040006, k040106, k040716, k050089, k050555, k051689, k053241, k060214, k060217, k060218, k060493, k070809, k082538, k082852, k082913, k131331, and k14046.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 panel phoenix pmic-110 the user noted high mics for both patient and qc isolates.The user stated "patient specimens with staphylococcus aureus resulting as resistant to vancomycin (not often), cephazolin (not often), chloramphenicol (often), clindamycin (often), and ampicillin (often).When they repeat the panel, the drugs are then negative." the user verified the final result using a reference laboratory.It is also to be noted that the upstream instrument was found to be contaminated.No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: this complaint is for high mic results with staphylococcus aureus and enterococcus faecalis when using phoenix panel pmic-110 (catalog number 449036) batch number 5287187.The customer provided phoenix generated lab reports showing failed mic results for the investigation.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.Upon investigation from an onsite visit, it was discovered that the ap instrument was contaminated.It is recommended to perform routine decontamination on the instruments and environment.This complaint is unable to be confirmed for a panel performance issue.As no trends were identified, no corrective actions are slated at this time.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 pmic-110 the user noted high mics for both patient and qc isolates.The user stated "patient specimens with staphylococcus aureus resulting as resistant to vancomycin (not often), cephazolin (not often), chloramphenicol (often), clindamycin (often), and ampicillin (often).When they repeat the panel, the drugs are then negative." the user verified the final result using a reference laboratory.It is also to be noted that the upstream instrument was found to be contaminated.No health impact or consequence reported.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information b3.Date of event: (b)(6) 2026.

• Brand Name: PANEL PHOENIX PMIC-110
• 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: 24146322
• Report Number: 1119779-2026-00021
• Device Sequence Number: 21082137
• Product Code: LON
• UDI-Device Identifier: 30382904490363
• UDI-Public: (01)30382904490363(17)261008(10)5287187
• 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,Followup
• Report Date (Section B): 02/23/2026

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: 449036
• Device Lot Number: 5287187
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 01/23/2026; 02/23/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/05/2026; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• 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