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

Model Number EASYLINK INFORMATICS SYSTEM

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2014

Event Type  malfunction  

Event Description

The customer reported that an advia centaur instrument obtained a dose patient result, which was sent to the easylink system.The easylink system released a discordant coefficient of one result to the physician(s) laboratory information system, which did not include the word "dose".A corrected result was reported to the physician(s).The physician(s) contacted the patient, advising them they were not in remission.There are no reports of patient adverse health consequences due to the discordant dose result.

Manufacturer Narrative

The siemens headquarters support center (hsc) was contacted by the customer.The hsc evaluated the instrument data and determined that the easylink database driver had a deadlock and was unable to read or write data in the system database.The hsc determined that when this occurs, the easylink will alert the user by displaying a system alert in the result manager screen.The user is able to access the error logs within the easylink communications directory and determine if the correct result was reported to the physician(s).The cause of the database driver deadlock is unknown.The customer reported a corrected result to the physician(s).The hsc determined that the easylink rules are functioning correctly.The instrument is performing within specifications.No further evaluation of the device is required.

Manufacturer Narrative

The initial mdr 2517506-2014-00360 was filed with the fda on november 25, 2014.Corrected data: initial mdr incorrectly lists the 510(k) number as k051087.Easylink data management system is 510 (k) exempt.Additional information (4/24/2015): siemens healthcare diagnostics has received complaints regarding reference ranges, sample reports, user-initiated sample/result actions, and auto-verification and quality control processing for the easylink¿ data management system software.Through internal investigation, siemens has confirmed issues with: custom reference ranges, user-initiated sample and result actions, auto-verification and quality control rules, and sample reports.An urgent medical device correction (umdc) entitled "easylink data management system limitations and software issues" was sent to customers in the united states and an urgent field safety notice (ufsn) entitled "easylink data management system limitations and software issues" was sent to customers outside the united states in may 2015.The umdc/ufsn explain the reason for the correction and actions customers can take to prevent these issues from occurring.

• Brand Name: EASYLINK
• Type of Device: INFORMATICS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; newark DE 19702
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, mailstop 514; po box 6101; newark DE 19714
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4278198
• MDR Text Key: 18540726
• Report Number: 2517506-2014-00360
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510(K)EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/31/2014

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: EASYLINK INFORMATICS SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 11/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2015
• 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
• Removal/Correction Number: 2517506-05/07/2015-001-C
• Patient Sequence Number: 1