MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ PMIC/ID-107; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY

Model Number 448607

Device Problem Device Ingredient or Reagent Problem (2910)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2022

Event Type  malfunction  

Event Description

It was reported that bd phoenix¿ pmic/id-107 misidentification occurring.The following information was provided by the initial reporter: hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: this complaint is not confirmed.This complaint is for misidentification of s.Aureus when using phoenix panel pmic/id-107 (448607) batch number 2165241.The customer did not provide panel returns or photos but provided isolate returns and lab reports for the investigation.To investigate, three (3) retention panels from complaint batch 2165241 were tested using customer returned isolates of s.Aureus 9916 on a phoenix m50 instrument and evaluated for identification results.In addition, one (1) control panel from the same material but different batch number were tested using customer returned isolates of s.Aureus 9916 on a phoenix m50 instrument and evaluated for identification results.Results of the investigation reveal all four (4) panels identifying as s.Aureus.Therefore, this complaint is not confirmed.A review of quality notifications revealed no quality notifications generated on the complaint batch.A review of complaints revealed one (1) additional complaint on the complaint batch, not related to this defect.Complaint trending was performed, and no trends were identified associated with this defect.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.

Event Description

It was reported that bd phoenix¿ pmic/id-107 misidentification occurring.The following information was provided by the initial reporter: hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.

• Brand Name: BD PHOENIX¿ PMIC/ID-107
• Type of Device: SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15936140
• MDR Text Key: 308086530
• Report Number: 1119779-2022-01468
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 30382904486076
• UDI-Public: 30382904486076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023273
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

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
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 448607
• Device Catalogue Number: 448607
• Device Lot Number: 2165241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1