MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD SYNAPSYS LABORATORY SOLUTIONS; DATA MANAGEMENT SYSTEM

Catalog Number 444150

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2019

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.(b)(4).

Event Description

During an investigation into another customer complaint it was discovered that the bd synapsys laboratory solutions mis-associated patient data.Further investigation showed that the data for the cultures in question revealed an isolate record on those cultures had a mis-association on it.The isolate records contained a culture protocol identifier for one culture/specimen, but contained the specimen identifier for a different specimens.This caused the isolates to be connected to two different specimens.A mis-association could lead to erroneous results being reported out.

• Brand Name: BD SYNAPSYS LABORATORY SOLUTIONS
• Type of Device: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 7 loveton circle; sparks MD 21152
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10111007
• MDR Text Key: 205106946
• Report Number: 1119779-2020-00123
• 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
• Report Date: 05/27/2020

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: 444150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 06/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2018
• 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
• Patient Outcome(s): Other