MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM; DATA MANAGER

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Device Issue (2379)

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

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer stated that the sample in question was a fluid sample of unknown origin and not a serum cea.Ccc advised that the method is not validated for this use.A siemens regional support center (rsc) specialist obtained remote access to the instrument and discovered that the relative light unit (rlu) result aspect overwrote the dose in centralink thus '0' (dose) displayed at advia centaur xp instrument but '1336' (rlu) was displayed at centralink.The rsc specialist identified the cause was due to a missing "result selector" in the centralink setting for the fluid cea method.When a "result selector" is not assigned, all of test result aspects (dose, rlu, etc) are received by centralink and only the last aspect is saved.The rsc specialist concluded that the issue was due to incorrect test setup by the customer.The configuration has been corrected.The cause of erroneous cea results on centralink was due to a configuration issue.Using fluid cea is off label use.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Erroneous, fluid carcinoembryonic antigen (cea) results were transmitted to the centralink data management system.The cea result displayed in the advia centaur xp instrument was '0', however, centralink displayed a result of 1336.The customer repeated the sample undiluted on the same instrument, and another '0' result was obtained.The customer stated that the initial results received on centralink, in duplicate resulted 1464 and 1536.The initial result displayed on the centralink was not reported to the physician(s).It is unknown if the correct result was reported to the physician(s).There are no known reports of adverse health consequences due to the erroneous cea results.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6142812
• MDR Text Key: 61406729
• Report Number: 2432235-2016-00744
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/02/2016

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: Health Professional
• Device Model Number: CENTRALINK DATA MANAGEMENT SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/02/2016
• 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