MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. CENTRALINK DATA MANAGEMENT SYSTEM; LABORATORY INFORMATION SYSTEM

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem No Apparent Adverse Event (3189)

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

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report an incompatibility of patient names, test, and results reported from the centralink data management system (centralink) and atellica instrument.A siemens customer service engineer (cse) performed troubleshooting and no issues were found with the centralink or atellica instrument.The customer uses two preceding characters for each new year and are not included in the sid the system uses.It was observed that the old samples stored in the data management system (dms) software has not been archived.Siemens is investigating.

Event Description

Siemens was informed by the customer of an incompatibility of patient names and the test results prothrombin time (pt) and partial thromboplastin time (ptt) reported from the centralink data management system (centralink) for patient # 2 (sid (b)(6)).The customer had run hemoglobin a1c on the atellica instrument for patient # 2, however pt and ppt results were reported for the same sid (b)(6) associated with a different name (patient #1) run a year earlier ((b)(6) 2018).Due to the discrepancy, results were not reported to the physician(s).There are no reports that treatment was prescribed or adverse health consequences due to the incompatibility of the patient names, tests and results.

Manufacturer Narrative

Siemens filed an initial mdr (b)(4) on (b)(6)2019 for an incompatibility of patient names and the test results prothrombin time (pt) and partial thromboplastin time (ptt) reported from the centralink data management system (centralink) for patient # 2 (b)(6).Additional information (19-dec-2019): siemens has reviewed the information provided and a potential product issue was not identified.The system log files are no longer available.The troubleshooting and/or maintenance of manually purging the old samples in the data management system (dms) for sample identification (sid) archiving compatibility was performed and the system is operational.The centralink dms is performing within specifications.No further evaluation of the device is required.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: LABORATORY INFORMATION SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9351262
• MDR Text Key: 220568818
• Report Number: 2432235-2019-00414
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/08/2020

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
• Initial Date Manufacturer Received: 10/26/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1