MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. SYNGO LAB DATA MANAGER; CALCULATOR/DATA PROCESSING MODULE

Model Number SYNGO LAB DATA MANAGER

Device Problems Nonstandard Device (1420); Device Displays Incorrect Message (2591)

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

Event Date 02/10/2014

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has identified five feature issues with the (b)(4) lab data manager.The issues pertain to result unit conversions, quality control processing, virus protection, system performance degradation, and orders received from lis being rejected.An urgent medical device correction (umdc) entitled "(b)(4) lab data manager system software issues" was sent to customers in the united states in august 2015.An urgent field safety notice (ufsn) entitled "(b)(4) lab data manager system software issues" was sent to customers outside of the united states in (b)(6) 2015.The umdc and ufsn describe the issues and provide actions the customer can take to prevent and mitigate the issues.

Event Description

A siemens customer service engineer at a customer site discovered that deleted quality control (qc) results on a (b)(4) lab data manager would come back.When a new qc result contains an error code, the user can exclude the result and proceed with running qc.However, if a second result with an error code occurs and the user tries to exclude the result, the error from the first qc result replaces the second error.The user must then manually exclude the error result a second time.If the auto verification feature is being used, all results will be held.There are no known reports of adverse health consequences due to this issue.

• Brand Name: SYNGO LAB DATA MANAGER
• Type of Device: CALCULATOR/DATA PROCESSING MODULE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration number: 1226181; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 5065898
• MDR Text Key: 25921845
• Report Number: 2517506-2015-00181
• 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: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/20/2015

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/20/2015
• Initial Date FDA Received: 09/09/2015
• 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: 2517506-09/01/2015-001-C
• Patient Sequence Number: 1