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

Model Number SYNGO LAB DATA MANAGER

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Hemolysis (1886)

Event Date 07/25/2014

Event Type  malfunction  

Event Description

The customer stated that when testing a potassium sample, the result should have been held for hemolysis on the syngo lab data manager application software.The potassium result was not reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the potassium result not being held for hemolysis.

Manufacturer Narrative

The siemens headquarters support center (hsc) was contacted by the customer.The hsc evaluated the instrument data and determined that the customer made changes to the syngo lab data manager group 7 rule.The siemens syngo lab data manager operators guide clearly states to contact siemens regarding any changes pertaining to applying rules and activating rules.The cause of the potassium sample not being held for hemolysis on the syngo lab data manager application software was due to user error.The hsc instructed the customer to change group 7 rule to rule 2 in the rules engine and to successfully reorder priorities.The hsc determined that the syngo lab data manager application software is performing to specification.No further evaluation of the device is required.

• 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; registration number: 1226181; brookfield CT 06804
• Manufacturer Contact: john nelson ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 4029478
• MDR Text Key: 4843151
• Report Number: 2517506-2014-00175
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2014

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: SYNGO LAB DATA MANAGER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2014
• Initial Date FDA Received: 08/21/2014
• 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
• Patient Sequence Number: 1