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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Device Operational Issue (2914)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2017, the customer contacted a siemens customer care center and stated that the issue occurred after the centralink software was upgraded.On 07-dec-2017, siemens customer service engineer (cse) and regional support center (rsc) specialist remotely connected to the customer's system, and reviewed the allergy test spe_e1 (cat dander - epithelium) for "unit, patient/control" result selector in method setting.They also reviewed the immulite 2000 xpi's present aspects, translator in specific options, and immulite 2000 xpi communication log, review and edit screen for a patient sample.Upon the rsc specialist's recommendation, the cse changed allergy test spe_e1 (added unit ku/l as aspect, assigned aspect in method as result selector, and synchronized immulite 2000 xpi service and translator).The cse indicated that the required configuration will be applied to other impacted allergy tests.On (b)(6) 2017, the issue was resolved.The cause of the allergy class being sent instead of measured values from centralink to lis is unknown.The device is performing within specifications.No further evaluation of device is required.Mdr 2432235-2017-00662 was filed for the same event.

Event Description

A centralink data management system sent allergy class instead of measured values for the patient samples on the customer's laboratory information system (lis).The initial value was displayed on the centralink as a previous run result and repeat value was displayed as an allergy class under current run.The initial values i.E.The allergy class instead of values were reported to the physician(s).The corrected values were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the allergy class being sent instead of measured values.

Manufacturer Narrative

The initial mdr 2432235-2017-00663 was filed on 26-dec-2017.The first supplemental mdr 2432235-2017-00663_s1 was filed on 08-jan-2018.Additional information (22-jan-2018): a siemens headquarters support center (hsc) specialist reviewed the event data, including log information and system configuration.The hsc specialist concluded that the issue was due to the incorrect system configuration.Mdr 2432235-2017-00662_s1 is filed for the same issue.

Manufacturer Narrative

The initial mdr 2432235-2017-00663 was filed on 26-dec-2017.Additional information (11-dec-2017): additional information has been provided regarding allergen tests which were run as a part of 3g allergy specific ige panel for sample id (b)(6) on (b)(6) 2017.Additional information (12-dec-2017): a siemens customer service engineer (cse) indicated that the required configuration will be applied to other impacted allergy tests.The cse verified that the required changes for allergy tests were performed to resolve the issue.The laboratory information system was also adjusted to support the additional information (unit sent as aspect in result record), otherwise the result would not be registered there.

• 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 10040 ; EI 10040
• Manufacturer Contact: shweta gulati ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242870
• MDR Report Key: 7145858
• MDR Text Key: 96118751
• Report Number: 2432235-2017-00663
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2018

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 12/11/2017; 01/22/2018
• Supplement Dates FDA Received: 01/08/2018; 02/09/2018
• 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