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

Catalog Number	448606
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	11/13/2024
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, k021954, k022172, k023273, k023301, k024152, k030677, k031306, k031679, k031679, k032131, k033784, k033907, k040006, k040106, k040716, k050555, k051689, k053241, k060214, k060217, k060218, 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/id-106 a patient isolate (s.Lugdunensis) was misidentified as s.Capitis.The user noted that the results from a molecular testing platform gave the result staph lugdunensis.Repeat testing was performed with a reference laboratory.No health impact or consequence reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 18-nov-2024.Investigation summary: this complaint is for misidentification of staphylococcus lugdenensis when using phoenix panel pmic/id-106 (catalog number 448606) batch number 4254739.The customer returned panels, isolates and phoenix generated lab reports for the investigation.The customer provided phoenix lab reports show an isolate identified as staphylococcus capitis when using the complaint batch.The customer returned isolate was verified and labeled as s.Lugdenensis 11106808 with a bruker maldi biotyper.To investigate, customer returned panels were tested using customer returned isolate s.Lugdenensis 11106808 on a phoenix m50 machine and evaluated for identification results.Next, retention panels from the complaint batch and control panels were tested using customer returned isolate s.Lugdenensis 11106808 on a phoenix m50 machine and evaluated for identification results.Some of the retention and customer returned panels tested with customer returned isolate s.Lugdenensis 11106808 did not correctly identify the isolate as s.Lugdenensis.All other panels identified the isolate correctly as s.Lugdenensis; therefore, this complaint is confirmed for misidentification.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.As no trend has been identified, no corrective actions are slated at this time.Bd will continue to monitor for trends and take action as necessary.
Event or Problem Description
It was reported while using the bd phoenix¿ pmic/id-106 a patient isolate (s.Lugdunensis) was misidentified as s.Capitis.The user noted that the results from a molecular testing platform gave the result staph lugdunensis.Repeat testing was performed with a reference laboratory.No health impact or consequence reported.

• Brand Name: BD PHOENIX¿ PMIC/ID-106
• Common Device Name: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY
• 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: 20880205
• Report Number: 1119779-2024-00969
• Device Sequence Number: 21064849
• Product Code: LON
• UDI-Device Identifier: 30382904486069
• UDI-Public: (01)30382904486069(11)240910(17)250905(10)4254739
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/21/2025

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: 09/05/2025
• Device Catalogue Number: 448606
• Device Lot Number: 4254739
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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