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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD EPICENTER¿ SINGLE USER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
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BECTON, DICKINSON & CO. (SPARKS) BD EPICENTER¿ SINGLE USER SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE Back to Search Results
Catalog Number 443972
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2023
Event Type  malfunction  
Event Description
It was reported that during use with the bd epicenter¿ single user software, tests were associated with the incorrect tests.There was no report of patient impact.The following information was provided by the initial reporter: mgit g&d tests are not associated to the correct test in their lis.
 
Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H.6 investigation summary: customer sent an email to report the mgit g&d test are not associated to the correct test in their lis from epicenter (443972/ sn (b)(6)).Adjustments in the customer lis interface settings resolved this issue.This is not a confirmed complaint of a bd product.Complaints for software were under statistical control for the month of october.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 during use with the bd epicenter¿ single user software, tests were associated with the incorrect tests.There was no report of patient impact.The following information was provided by the initial reporter: mgit g&d tests are not associated to the correct test in their lis.
 
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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
jennifer suh
7 loveton circle
sparks, MD 21152
4103164000
MDR Report Key18078237
MDR Text Key327445980
Report Number1119779-2023-01208
Device Sequence Number1
Product Code JQP
UDI-Device Identifier00382904439729
UDI-Public(01)00382904439729
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
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 02/20/2024
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 Number443972
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/19/2023
Initial Date FDA Received11/06/2023
Supplement Dates Manufacturer Received02/20/2024
Supplement Dates FDA Received03/13/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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