MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX SMIC/ID-101; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Model Number	448802
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	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Pma / 510(k)#: the bd phoenix¿ smic/id-101 is an antimicrobial resistance panel consists of a combination of the following 510k numbers: k050745, k050747, k050780, k050865, k050881, k050946, k050982, k051109, k051138, k051204, k051266, k051272, k051692, k062206.
Event or Problem Description
It was reported that while using bd phoenix¿ smic/id-101 a mis-id was observed by the laboratory personnel.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that mis-id of strep peuno to strep mitis occurred.(b)(6) 2021 18:07:55 (gmt) customer problem: customer reporting mis-id of strep peuno to strep mitis.".
Event or Problem Description
It was reported that while using bd phoenix¿ smic/id-101 a mis-id was observed by the laboratory personnel.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: " it was reported that mis-id of strep peuno to strep mitis occurred.Nitasha assi : 2021-04-12 18:07:55 (gmt) ¯ customer problem: customer reporting mis-id of strep peuno to strep mitis.".
Additional Manufacturer Narrative
Investigation summary: this complaint is for misidentification of streptococcus pneumoniae as streptococcus mitis when using phoenix panel smic/id-101 (448802) batch number 0203650.The customer did not provide samples, isolates, or lab reports for investigation.To investigate, a total of two (2) retention panels from the complaint batch were tested using qc isolates of streptococcus pneumoniae (a49619).Both panels tested during investigation identified correctly as streptococcus pneumoniae.Since the identification results yielded during investigation were satisfactory the complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed three (3) additional complaints on the complaint batch that are unrelated to this complaint.Complaint trending was performed and a trend was found for this defect (s.Pneumoniae identifying as s.Mitis) in february 2020.Based on the severity and rate of the defect, a corrective and preventive action (capa) investigation was not initiated.Bd id/ast plant quality will continue to monitor for trends associated with this defect, including changes in severity and rate.

• Brand Name: BD PHOENIX SMIC/ID-101
• Common Device Name: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11786949
• Report Number: 1119779-2021-00775
• Device Sequence Number: 3938049
• Product Code: LON
• UDI-Device Identifier: 30382904488025
• UDI-Public: 30382904488025
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/18/2021

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: 07/31/2021
• Device Model Number: 448802
• Device Catalogue Number: 448802
• Device Lot Number: 0203650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1