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	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd phoenix¿ pmic/id-106 that there was an incorrect vancomycin mic result reported out on one patient.The following information was provided by the initial reporter: "customer reporting incorrect ast for product 448606 lot no.3150521.Customer initially received a result of van mic = 4 and sir of intermediate.Customer stated that they reran the panel twice and mic was = 1 and sir = susceptible.Initial run was released to the chart.After further investigation, customer is not able to confirm if patient care was changed.".
Additional Manufacturer Narrative
G5: pma/510(k)#: 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 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
The following information has been updated with corrected and/or additional information: b.5.Describe event or problem: it was reported while using bd phoenix¿ pmic/id-106 that there was a false resistant result reported out on one patient.Customer is unable to confirm if there was patient impact.H.6.Investigation summary: this complaint is for high mic results for vancomycin (va) when using phoenix panel pmic/id-106 (catalog number 448606) batch number 3150521.The customer did not provide panel returns, isolates or lab reports but provided binary files for the investigation.To investigate, three retention samples each from complaint batch 3150521 were inoculated with qc isolates staphylococcus aureus a29213 and enterococcus faecalis a29212 to observe for va mic results.The investigation returned all six panels with satisfactory va mic results, therefore this complaint is not confirmed.A review of the binary files was determined not to be required based on the results of the investigation.For further investigation, the batch history records were 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.Please continue to communicate any additional concerns.
Event or Problem Description
It was reported while using bd phoenix¿ pmic/id-106 that there was a false resistant result reported out on one patient.Customer is unable to confirm if there was 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17990978
• Report Number: 1119779-2023-01169
• Device Sequence Number: 8199199
• Product Code: LON
• UDI-Device Identifier: 30382904486069
• UDI-Public: 30382904486069
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K020322
• 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): 03/07/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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