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	12/17/2025
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, 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 a patient isolate (enterococcus faecium) had a low mic (false susceptible) result for the drug vancomycin.No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: this complaint is for low mic results for vancomycin (va) with enterococcus faecium when using panel phoenix pmic-110 (catalog number 449036) batch number 5211429.The customer returned a photo of results for the investigation.The batch history record was satisfactory, and no quality notifications were generated during manufacturing and inspection.Complaint trending was analyzed, and no current trends were identified associated with this defect.Historical trending was reviewed and there were no trends for low mic results for panel sku 449036.To investigate, retention panels from the complaint batch were inoculated with in house isolate enterococcus faecium to observe for va mic results.Next, control panels from the same material but different batch were inoculated with in house isolate enterococcus faecium to observe for va mic results.The investigation returned all panels with resistant va mic and sir results for their inoculated isolates.Therefore, this complaint is unable to be confirmed.As no complaint trend has been identified, no actions are indicated at this time per bd procedures.Bd will continue to monitor for trends and take action as necessary.
Event or Problem Description
It was reported while using the panel phoenix pmic-110 a patient isolate (enterococcus faecium) had a low mic (false susceptible) result for the drug vancomycin.No health impact or consequence reported.

• 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: 24045057
• Report Number: 1119779-2025-05558
• Device Sequence Number: 10482814
• Product Code: LON
• UDI-Device Identifier: 30382904490363
• UDI-Public: (01)30382904490363(17)260722(10)5211429
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 03/31/2026

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 Expiration Date: 07/22/2026
• Device Catalogue Number: 449036
• Device Lot Number: 5211429
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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