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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Patient Data Problem (3197)

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

Event Date 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Ccc evaluated the instrument data and discovered that patient b was scheduled manually by the operator who assigned it the sample id of patient a.The cause of the patient identification number being assigned to the incorrect patient was user error.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The test result of one patient sample (patient b) was uploaded on another patient sample (patient a) on a centralink data management system.No incorrect patient results were reported to the physician(s) as a result of the event.There are no reports of patient intervention or adverse health consequences due to a test result uploaded on the incorrect patient.

• 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: 4974704
• MDR Text Key: 25137467
• Report Number: 2432235-2015-00353
• 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
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• 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
• Date Manufacturer Received: 07/15/2015
• 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
• Patient Sequence Number: 1