MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem False Negative Result (1225)

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

Event Date 09/23/2021

Event Type  malfunction  

Event Description

The customer reported a false negative and a 9.907 miu/ml beta human chorionic gonadotropin (bhcg) result from the centralink data management system, and the results were questioned by the physician(s).The customer informed siemens that centralink had an incorrect calculation rule for bhcg.The customer identified the correct rule and determined the correct result for the patient was positive.The customer issued a corrected report.There are no known reports of patient intervention or adverse health consequences due to the false negative result reported by the centralink data management system.

Manufacturer Narrative

A united states customer contacted siemens customer care center.Siemens dispatched a customer service engineer to the customer site.The cse performed troubleshooting and assisted the customer in changing the beta human chorionic gonadotropin (bhcg) calculation rule from 10 to 9.5.The customer changed the calculation rule for bhcg and noted that a numeric value > or equal to 9.5 is a positive result, and a numerical value <9.5 is a negative result.Siemens reviewed the information provided and determined that the centralink data management system was performing as expected with rounding to a whole number and calculation rule settings.The troubleshooting performed by the cse resolved the issue, and the centralink data management system is performing according to specifications.No further evaluation of the device was required.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: CENTRALINK DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 12661792
• MDR Text Key: 284187498
• Report Number: 2432235-2021-00259
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CENTRALINK DATA MANAGEMENT SYSTEM
• Device Catalogue Number: 10816521
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR