MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. SYNGO

Model Number SYNGO

Device Problem Device Issue (2379)

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

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer call center (ccc) to report the issue.A siemens regional support center (rsc) representative evaluated the lis log from the customer site and found an incorrect software rule in syngo.The instrument sending result data to syngo sends test data in the dose field and an instrument parameter in the coefficient (coff) field.The incorrect rule caused syngo to replace the dose result with the value sent for coff.In the reported event the dose value was a triiodothyronine (t3) test result of 2.72 ng/ml and the coff was 1.0.A result of 1.0 was reported to the physician.It is unknown if the dose value was reported.The test result for the different sample is unknown.A siemens technical support specialist (tsc) corrected the software rule in syngo.The customer reportedly performed a lookback and did not find other occurances of discordant results.The cause of the discordant falsely low t3 test result is an incorrect software rule in syngo.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

A falsely low discordant triiodothyronine (t3) result was obtained on a syngo data management system for a single patient sample.The initial result was provided to the physician.A different sample was used for repeat testing.The value of the repeat result is unknown.There are no known reports of patient intervention or adverse health consequences due to the falsely low t3 test results.

• Brand Name: SYNGO
• Type of Device: SYNGO
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 7430340
• MDR Text Key: 105665139
• Report Number: 2517506-2018-00269
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/13/2018

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: SYNGO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/13/2018
• 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