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	12/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd phoenix¿ pmic id-106, a false vancomycin resistance to staph aureus was reported for one (1) patient sample.The sample was sent out to a reference lab and vancomycin resistance was unable to be confirmed.There was no report of patient impact.
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: g.5: 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, k131331.H.3: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: this complaint is for high mic results for vancomycin (va) with staphylococcus aureus when using phoenix panel pmic/id-106 (catalog number 448606) batch number 3192572.The customer did not provide panel returns or phoenix generated lab reports but provided isolates for the investigation.To investigate, four retention samples from complaint batch 3192572 were inoculated with customer returned isolate s.Aureus to observe for va mic results.In addition, two control panels from the same material but different batch were inoculated with customer returned isolate s.Aureus to observe for va mic results.The investigation returned all six panels with satisfactory va mic results; therefore this complaint is not confirmed.The batch history record was satisfactory, and no quality notifications were generated during manufacturing and inspection.A review of complaints revealed no additional complaints on batch 3192572, not related to this defect.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.
Event or Problem Description
It was reported when using the bd phoenix¿ pmic/id-106, a false vancomycin resistance to staph aureus was reported for one (1) patient sample.The sample was sent out to a reference lab and vancomycin resistance was unable to be confirmed.There was no report of patient impact.

• 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: 18537516
• Report Number: 1119779-2023-01510
• Device Sequence Number: 7588065
• Product Code: LON
• UDI-Device Identifier: 30382904486069
• UDI-Public: (01)30382904486069
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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: 07/11/2024
• Device Catalogue Number: 448606
• Device Lot Number: 3192572
• 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: 12/28/2023
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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