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 Factors Issue (2948)

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

Event Date 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse discovered that the assay setup was not specimen specific and the assay was typed incorrectly in the range rule, all of which were corrected.The customer requested all results to auto-verify, and a change was made to the "hold" rule.The method was tested for (b)(6) being reported out was a human factors issue.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The (b)(6) assay was not uploading from the advia centaur instrument to the syngo lab data manager.The customer was manually entering results and a (b)(6) was entered in error and reported to the physician(s).The customer made a corrected report to a (b)(6).There are no known reports of patient intervention or adverse health consequences due to the (b)(6).

• 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 (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown 10591 ; 9145243105
• MDR Report Key: 5420514
• MDR Text Key: 38330811
• Report Number: 2517506-2016-00018
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 01/15/2016

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: No Information
• 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: 01/15/2016
• Initial Date FDA Received: 02/09/2016
• 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