MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD EPICENTER¿ SINGLE USER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 444165

Device Problem False Positive Result (1227)

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

Event Date 04/20/2023

Event Type  malfunction  

Event Description

It was reported that while using epicenter¿ single user software an e.Coli isolate and when the result is obtained mic states 8 and according to clsi it should be intermediate but is giving a susceptible result, no rules are triggered.The following information was provided by the initial reporter: customer states that when testing e.Coli, mic found was 8 which according to clsi and fda is an intermediate result, but phoenix system is giving a sensible interpretation.Customer is using panel 449289, panel phoenix nmic/id-307 lot no.3010436.

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: customer contacted bd support regarding their epicenter nuc 444165 sn (b)(6).The customer states that when testing e.Coli, mic found was 8 which according to clsi and fda is an intermediate result, but phoenix system is giving a different interpretation.Customer is using panel 449289, panel phoenix nmic/id-307 lot no.3010436.Investigation showed that the breakpoints in the software did not align with the breakpoints of the clsi/fda.The root cause is unknown; however the software for this interpretation stems from the phoenix instrument and this is therefore not a failure of the epicenter.The complaint is unconfirmed against the epicenter.Dhr review is not required because the part that allegedly failed is not tested as part of the manufacturing process but is shipped separately and tested during installation.Service history review shows no prior complaints opened for this issue.Quality did not receive samples for this complaint and therefore returned sample analysis could not occur.The root cause is unknown.Review of risk management files confirms there are no new or modified risks associated with this failure mode.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.H3 other text : see h10.

Event Description

It was reported that while using epicenter¿ single user software an e.Coli isolate and when the result is obtained mic states 8 and according to clsi it should be intermediate but is giving a susceptible result, no rules are triggered.The following information was provided by the initial reporter: customer states that when testing e.Coli, mic found was 8 which according to clsi and fda is an intermediate result, but phoenix system is giving a sensible interpretation.Customer is using panel 449289, panel phoenix nmic/id-307 lot no.3010436.

Manufacturer Narrative

The following fields were updated due to additional information: customer contacted bd support regarding their epicenter nuc (b)(4) sn (b)(6).The customer states that when testing e.Coli, mic found was 8 which according to clsi and fda is an intermediate result, but phoenix system is giving a different interpretation.Customer is using panel 449289, panel phoenix nmic/id-307 lot no.3010436.Investigation showed that the breakpoints in the assay were not determined by or a failure of the epicenter software.The root cause of the failure was not able to be determined with the information provided.This complaint is unconfirmed.Dhr review is not required because the part that allegedly failed is not tested as part of the manufacturing process but is shipped separately and tested during installation.Service history review shows no prior complaints opened for this issue.Quality did not receive samples for this complaint and therefore returned sample analysis could not occur.The root cause is unknown.Review of risk management files confirms there are no new or modified risks associated with this failure mode.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.

Event Description

It was reported that while using epicenter¿ single user software an e.Coli isolate and when the result is obtained mic states 8 and according to clsi it should be intermediate but is giving a susceptible result, no rules are triggered.The following information was provided by the initial reporter: customer states that when testing e.Coli, mic found was 8 which according to clsi and fda is an intermediate result, but phoenix system is giving a sensible interpretation.Customer is using panel 449289, panel phoenix nmic/id-307 lot no.3010436.

• Brand Name: BD EPICENTER¿ SINGLE USER SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16935384
• MDR Text Key: 315488985
• Report Number: 1119779-2023-00556
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131331
• 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,Followup
• Report Date: 06/30/2023

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 Catalogue Number: 444165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 06/27/2023; 06/30/2023
• Supplement Dates FDA Received: 06/30/2023; 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• 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