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 05/21/2022

Event Type  malfunction  

Event Description

It was reported that while using bd epicenter¿ single user software false positive results were obtained by the laboratory personnel.The customer stated that results were reported out, but it is unknown if there was patient impact.The following information was provided by the initial reporter: " customer reported oxacillin discrepancy.Epi reporting oxacillin 0.5 as resistant and its susceptible according to (b)(6)for staph epidermidis.Reported out first on (b)(6) and clinician querying the result.Customer thinks patient management treatment might have changed to result sent out.Customer would like to know what guidelines epi is using.Pud is v6.91a".

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.

Manufacturer Narrative

H.6 investigation summary: this is not a confirmed complaint of a bd product.Complaints for software were under statistical control for the month of june.No trends indicated.Device history record review is not required for standalone software.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

It was reported that while using bd epicenter¿ single user software false positive results were obtained by the laboratory personnel.The customer stated that results were reported out, but it is unknown if there was patient impact.The following information was provided by the initial reporter: "customer reported oxacillin discrepancy.Epi reporting oxacillin 0.5 as resistant and its susceptible according to clsi for staph epidermidis.Reported out first on 21st may and clinician querying the result.Customer thinks patient management treatment might have changed to result sent out.Customer would like to know what guidelines epi is using.Pud is v6.91a.".

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14862467
• MDR Text Key: 303238052
• Report Number: 1119779-2022-00942
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 12/19/2022

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 Catalogue Number: 444165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• 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