MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. SYNGO LAB DATA MANAGER APPLICATION SOFTWARE

Model Number SYNGO LAB DATA MANAGER APPLICATION SOFTWARE

Device Problem Human-Device Interface Problem (2949)

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

Event Date 01/10/2014

Event Type  malfunction  

Event Description

The operator of a syngo lab data manager set up a user defined rule for alkaline phosphatase (alpi).A serum sample should have been held with a comment, but the comment was not added.The sample was held for another reason and the result was not reported until after repeat.There are no known reports of adverse health consequences due to the syngo lab data manager not adding the comment for alpi.

Manufacturer Narrative

The customer contacted the siemens technical solutions center (tsc).During troubleshooting, it was determined that the alpi user defined assay had been incorrectly configured by the customer.An incorrect unit box was selected from the drop down list.The cause of the syngo lab data manager not adding a relevant comment to a sample so that the sample would be held was incorrect configuration by the customer.The instrument is performing according to specifications.No further evaluation of the device is required.

Manufacturer Narrative

The initial mdr 2517506-2014-00037 was filed on february 4, 2014.Additional information (05/12/2014): siemens healthcare diagnostics has investigated the instances of results being released to the laboratory information system when they should have been held for review.Siemens healthcare diagnostics has confirmed that certain configuration parameters selected during configuration of reference ranges for assays may cause the reference ranges to not hold results as expected.Urgent medical device correction (umdc) 14-30 entitled "syngo lab data manager: custom reference range and sample report issues" was sent to customers in the united states in may 2014.Urgent field safety notice (ufsn) 14-29 entitled "syngo lab data manager: custom reference range and sample report issues" was sent to customers outside of the united states in may 2014.The umdc/ufsn instructs customers to review the custom reference ranges they currently have in place, remove units that appear to be duplicates from the units configuration screen, and edit the ranges that have the improper configuration for sample fluid type, units, or equipment model.

Manufacturer Narrative

The initial mdr 2517506-2014-00037 was filed on february 4, 2014.The first supplemental mdr 2517506-2014-00037_s1 was filed on may 20, 2014.Additional information (05/22/2014): correction/removal reporting number has been updated.

• Brand Name: SYNGO LAB DATA MANAGER APPLICATION SOFTWARE
• Type of Device: SYNGO LAB DATA MANAGER APPLICATION SOFTWARE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; newark DE 19702
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 3606963
• MDR Text Key: 15821027
• Report Number: 2517506-2014-00037
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2014

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: Other
• Device Model Number: SYNGO LAB DATA MANAGER APPLICATION SOFTWARE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 02/04/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/20/2014; 05/29/2014
• 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: 2517506-05222014-002-C
• Patient Sequence Number: 1