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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Human Factors Issue (2948)

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

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare determined that the cause of the discordant results was due to a calculation error typed into a new centralink installation at the customer site.The calculation was incorrectly configured to multiply the ratio by 1000 instead of 100.The customer contacted a siemens technical support center (tsc).Tsc assisted the customer in editing the calculation.Patient results were verified as reporting correctly into meditech by the customer.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant results were obtained with the microalbumin to urine creatinine ratio calculation performed by the centralink data management system.The discordant results were falsely elevated by a factor of 10, and were reported to the physician(s).Approximately 450 patient results were impacted.The customer reported at least one patient had their blood pressure medicine increased.The patient complained about dizziness and reduced his medicine.No other details were provided by the customer.The discordant results were obtained as a result of a calculation error in the centralink data management system.The physician(s) were notified of the error and corrected reports were issued.

• 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: 5991943
• MDR Text Key: 56103918
• Report Number: 2432235-2016-00589
• 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: 09/30/2016

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: 09/06/2016
• Initial Date FDA Received: 09/30/2016
• 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