MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD PHOENIX¿ PMIC-106; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Catalog Number	448416
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	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G5.Pma / 510(k)#: k020322, k021954, k022172, k023273, k023301, k024152, k030677, k031306, k031679, k031679, k032131, k033784, k033907, k040006, k040106, k040716, k050555, k051689, k053241, k060214, k060217, k060218, k060493, k082538, k082852, k082913, and k131331.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¿ pmic-106 no mic was given for the drug levofloxacin for a patient enterococcus faecium isolate (424161535982).No health impact or consequence reported.
Event or Problem Description
It was reported while using the bd phoenix¿ pmic-106 no mic was given for the drug levofloxacin for a patient enterococcus faecium isolate (424161535982).No health impact or consequence reported.
Additional Manufacturer Narrative
Investigation summary: this complaint is for no mics for levofloxacin (lvx) with enterococcus faecium when using phoenix panel pmic-106 (catalog number 448416) batch number 4017431.The customer did not return phoenix generated lab reports, panels or isolates but provided binary files for the investigation.To investigate, three retention panels each of complaint batch 4017431 were inoculated with in house and qc isolates e.Faecium 4295 and e.Faecium a19434 and placed a phoenix m50 machine to evaluate for lvx mic results.Also, one control panel each from the same material but different batch were inoculated within house and qc isolates e.Faecium 4295 and e.Faecium a19434 and placed a phoenix m50 machine to evaluate for lvx mic results.All panels tested returned the expected results for lvx within parameters.This complaint is not confirmed.A review of the binary files was determined not to be required based on the results of 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.Bd will continue to monitor for trends and take action as necessary.

• Brand Name: BD PHOENIX¿ PMIC-106
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19481600
• Report Number: 1119779-2024-00486
• Device Sequence Number: 12774439
• Product Code: LON
• UDI-Device Identifier: 30382904484164
• UDI-Public: (01)30382904484164
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• 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): 09/03/2024

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: 01/10/2025
• Device Catalogue Number: 448416
• Device Lot Number: 4017431
• 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: 05/07/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• 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