MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX PMIC/ID-108; SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Model Number	448608
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	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported while testing with bd phoenix¿ pmic/id-108 an unspecified panel was used with different swabs and staph identifications did match.Multiple attempts have been made to obtain additional information, the customer has not responded.
Additional Manufacturer Narrative
Investigation: this complaint is due to misidentification of staphylococcus aureus as staphylococcus epidermidis when using pmic/id 108 (448608), however the batch number was not reported therefore is unknown.No lab reports, information on the complaint batch number, product returns or isolates were provided for investigation.To investigate, a total of five (5) retention panels from an available batch (batch # 0112330) were tested using the following isolates: in house strains of s.Aureus (4757 and a43300) as well as qc isolates of s.Aureus (a29213, 7146 and a25923) on a phoenix 100 instrument.All panels yielded the correct identification result of staphylococcus aureus.This complaint is not confirmed.The phoenix¿ user¿s manual states identification accuracy of 95.6% and 95.4% for gram-negative and gram-positive organisms respectively.A review of quality notifications was unable to be performed as no batch number was provided.A review of prior complaints was unable to be performed as no batch number was provided.Complaint trending was performed and a trend was found for this defect (s.Aureus identifying as s.Epidermidis) in january 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.
Event or Problem Description
It was reported while testing with bd phoenix¿ pmic/id-108 an unspecified panel was used with different swabs and staph identifications did match.Multiple attempts have been made to obtain additional information, the customer has not responded.

• Brand Name: BD PHOENIX PMIC/ID-108
• 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: 11404870
• Report Number: 1119779-2021-00417
• Device Sequence Number: 11895154
• Product Code: LON
• UDI-Device Identifier: 30382904486083
• UDI-Public: 30382904486083
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 04/05/2021

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 Model Number: 448608
• Device Catalogue Number: 448608
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1