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

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	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd phoenix¿ pmic/id-106 staphylococcus aureus was misidentified as staphylococcus epidermidis on one patient sample.There was no report of patient impact.
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information is as follows: g.5.Pma / 510(k)#: k131331, k020322, k021954, k022172, k023273, k023301, k024152, k030677, k031306, k031679, k032131, k033784, k033907, k040006, k040106, k040716, k050555, k051689, k053241, k060214, k060217, k060218, k060493, k082538, k082852, k082913.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd phoenix¿ pmic/id-106 staphylococcus aureus was misidentified as staphylococcus epidermidis on one patient sample.There was no report of patient impact.
Additional Manufacturer Narrative
The following fields were updated: d9.Device available for evaluation? yes returned to manufacturer on: 24-oct-2023 h6.Investigation summary: this complaint is for misidentification of staphylococcus aureus as staphylococcus epidermidis when using phoenix panel pmic/id-106 (catalog number 448606) batch number 3150521.The customer did not return phoenix generated lab reports but provided binary files, an isolate and panels under case number (b)(6)for the investigation.The isolate was verified as s.Aureus with bruker maldi biotyper.To investigate, two customer returned panels from complaint batch 3150521 was tested using customer returned isolate s.Aureus sj-4 on a phoenix m50 machine and evaluated for identification results.The two panels identified the isolate as s.Aureus, therefore, this complaint is not confirmed for misidentification.A review of the binary files was determined not to be required based on the results of the investigation.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed five additional complaints on complaint batch 3150521, one of which is related to this defect and unconfirmed.Complaint trending was performed, and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.H3 other text : see h10.

• Brand Name: BD PHOENIX¿ PMIC/ID-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: 18183090
• Report Number: 1119779-2023-01260
• Device Sequence Number: 7653063
• Product Code: LON
• UDI-Device Identifier: 00382904486068
• UDI-Public: (01)00382904486068
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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: 05/22/2024
• Device Catalogue Number: 448606
• Device Lot Number: 3150521
• 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: 10/30/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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