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	11/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown lot number: d.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.The information for the additional 510k is as follows: g5.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.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 when using the bd phoenix¿ pmic/id-106 a patient isolate was misidentified as strep uberis on its initial testing, it then identified as enterococcus faecalis when retested.The expected result was enterococcus faecalis.No health impact or consequence reported.
Event or Problem Description
It was reported when using the bd phoenix¿ pmic/id-106 a patient isolate was misidentified as strep uberis on its initial testing, it then identified as enterococcus faecalis when retested.The expected result was enterococcus faecalis.No health impact or consequence reported.
Additional Manufacturer Narrative
H.6.Investigation summary: this complaint is for misidentification when using phoenix panel pmic/id-106 (catalog number 448606) batch unknown.The customer noted misidentifications of enterococcus faecalis as streptococcus uberis when using pmic/id-106.The customer did not provide panel returns, isolate returns, phoenix generated lab reports or binary files for the investigation.Since a batch number was not provided, functional testing with retention samples could not be performed as part of the investigation.Therefore, this complaint is unable to be confirmed for a panel performance issue.A review of quality notifications could not be performed since a batch number was not provided.A review of complaints could not be performed since a batch number was not provided.Complaint trending was performed and no current trends were identified associated with this defect.

• 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: 18388685
• Report Number: 1119779-2023-01429
• Device Sequence Number: 11811313
• 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): 01/22/2024

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 Catalogue Number: 448606
• Device Lot Number: UNKNOWN
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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