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

Catalog Number 444150

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2020

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.

Event Description

It was reported that bd synapsys laboratory solutions caused a customer to update the incorrect sample.This could lead to erroneous results being reported out.The customer corrected the error immediately.No erroneous results were reported out and there was no change in patient treatment.

• 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: 10094276
• MDR Text Key: 194790275
• Report Number: 1119779-2020-00119
• 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: 05/21/2020

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: 02/22/2020
• Initial Date FDA Received: 05/27/2020
• 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