MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK

Model Number CENTRALINK

Device Problem Application Program Problem: Parameter Calculation Error (1449)

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

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).The instrument files were reviewed.During initial configuration of the system, centralink v16.03 -calculation rule for ualb (microalbumin) was configured incorrectly, causing incorrect results to be reported.A value of <3 was set instead of <0.3 for the calculation rule of microalbumin (ualb).This use error resulted in approximately 30 samples to be reported incorrectly.Errors occurred when the value of ualb was less than 3 mg/dl.The calculation rule configuration was corrected by resetting the rule value to <0.3.A look back was done to evaluate if any additional results were affected.The cause of the event was identified as a customer's use error.The instrument is operating within manufacturing specifications.No further evaluation of the device is required.

Event Description

A calculation error was observed on multiple patient samples on an atellica ch instrument using an centralink middleware.The customer set the calculation to <3 rather than <0.3 for microalbumin (ualb).The value was set manually.Incorrect test results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant ualb results.

• Brand Name: CENTRALINK
• Type of Device: CENTRALINK
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; chapel lane, swords co.; registration# 8020888; dublin, ; EI
• Manufacturer Contact: anu prasad ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 8130650
• MDR Text Key: 129251168
• Report Number: 2432235-2018-00448
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2018

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: Health Professional
• Device Model Number: CENTRALINK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1