MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. EASYLINK INFORMATICS SYSTEM

Model Number 10444799

Device Problem Human Factors Issue (2948)

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

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The ccc specialist was granted permission to remotely connect to the instrument.The ccc reviewed the available data and was not able to find the auto-released calcium (ca) result.A regional service center (rsc) specialist was contacted to review the complaint.The rsc specialist reviewed the instrument data.The rsc specialist found an issue in the easylink for error message e522.The error message is for "below assay range".The instrument, instead of holding the result for review by a technician, automatically released the result to the laboratory information system (lis).The instrument code was corrected, so that when an e522 error shows, the instrument will go into "i status" and hold the result for review.The cause of the e522 error coded calcium result being release was due to an improper instrument code.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A customer reported that their easylink system auto-released a calcium (ca) result with an error code e522 (below assay range) that should have been in "i status" (instrument status), holding the result and not releasing the result.The result was released to the physicians.The physician did not question the result.A repeat test was performed with a different sample on the same instrument.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the release of the calcium result.

• Brand Name: EASYLINK INFORMATICS SYSTEM
• Type of Device: EASYLINK INFORMATICS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5855202
• MDR Text Key: 51503417
• Report Number: 2517506-2016-00302
• 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: 08/08/2016

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: 10444799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 08/08/2016
• 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