MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY

Model Number 443624

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that while using bd phoenix¿ m50 automated microbiology system a misidentification was observed by the laboratory personnel.A pcr test was used to confirm the results.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "even if carbapenemase is positive using the cpo panel, all are negative after all even if pcr or carba 5 is used.".

Event Description

It was reported that while using bd phoenix¿ m50 automated microbiology system a misidentification was observed by the laboratory personnel.A pcr test was used to confirm the results.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " even if carbapenemase is positive using the cpo panel, all are negative after all even if pcr or carba 5 is used.".

Manufacturer Narrative

H6 investigation summary: a failure for incorrect results was reported on a phoenix m50 instrument (p/n 443624, s/n (b)(6).The customer reported that they were experiencing incorrect results for carbapenemase.Bd supported the concern by providing information on cpo (carbapenemase-producing organism) testing, sharing that the cpo result may be positive even if the mic (minimum inhibitory concentration) value of the carbapenem system is low.Additionally it was shared that, depending on the primers used, there may be some types of carbapenemase that do not hit.No field service work was done on the instrument in relation to this concern, and the customer monitored the issue and did not report further concerns.As no issue was noted with the instrument and the information provided concluded this concern from the customer, this is an unconfirmed failure of the instrument.The root cause of the initial concern is not known.No samples were expected to be received as part of this complaint, and therefore no samples were returned and no returned material investigation could occur.Dhr review is not required for this complaint as this complaint does not allege an early life failure or failure at installation and the configuration has changed since release from manufacturing due to service repairs/pms.Service history for this instrument revealed no previous cases related to false positive results.Bd quality will continue to closely monitor for trends associated with this complaint.No new risks or hazards, or changes to existing risks/hazards, were identified as a result of this complaint.H3 other text : see h10.

• Brand Name: BD PHOENIX¿ M50 AUTOMATED MICROBIOLOGY SYSTEM
• 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: 13114515
• MDR Text Key: 289100346
• Report Number: 1119779-2021-02062
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 00382904436247
• UDI-Public: 00382904436247
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

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 Model Number: 443624
• Device Catalogue Number: 443624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1