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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Incorrect Software Programming Calculations (1495)

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

Event Date 09/11/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Ccc discovered that when the (b)(4) confirmatory test sends a neutralization value, the centralink utilizes this number, which is not visible to the customer, to perform a calculation and interprets it as confirmed when the advia centaur analyzer has determined that the sample was not confirmed.A siemens regional support center (rsc) specialist removed the interpretation field from a centralink calculation rule and turned off the auto-verification feature, so that the customer has to type the interpretation of the confirmation.A siemens headquarters support center (hsc) specialist reviewed the event.The cause of the discordant interpretation is centralink accepted a percent neutralization value sent from the advia centaur instrument which was not visible to the customer on the instrument screen or the report.Centralink then used this value in a rule to interpret confirmation as confirmed.A siemens automation informatics specialist (ais) originally added a calculation to the confirmatory interpretation (conf_intr) test.The calculation for "conf_intr" was not looking at additional neutralizations, only the original value.The rule was added at the customer's request and tested onsite but not for additional neutralizations.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A centralink data management system interpreted a not confirmed (b)(6) result as confirmed.The discordant confirmed result was reported to the physician(s).This has occurred on two samples from the same patient, tested one month apart.The corrected non confirmed result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant (b)(6) confirmatory result.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; 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 avenue; tarrytown 10591 ; 9145243105
• MDR Report Key: 6123117
• MDR Text Key: 60873293
• Report Number: 2432235-2016-00722
• 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: 11/22/2016

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: 10/24/2016
• Initial Date FDA Received: 11/22/2016
• 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