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 08/15/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare determined that the cause of the discordant results was due to an equation error typed into a new centralink installation at the customer site.The equation was incorrectly configured to multiply the relevant ratio by 1000 instead of 100.A siemens technical application specialist corrected the equation.The instrument is performing according to specifications following the specialist's actions.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 physicians.The reported results likely influenced clinicians to prescribe treatment, such as blood pressure medication.Specific details were not provided by the customer.The discordant results were obtained as a result of an equation error in the centralink data management system.Once the equation was corrected and verified, 186 corrected reports were issued to the physicians.It is unknown if there were adverse health consequences due to the discordant results.

Manufacturer Narrative

The initial mdr 2432235-2016-00590 was filed on (b)(6) 2016.Additional information (b)(6) 2016: a siemens headquarter support center (hsc) specialist investigated the event.The customer's old centralink was being replaced with a new server, and rules and configurations were manually copied by siemens to the new server from a customer maintained workbook.On (b)(6) 2016, the customer emailed the workbook to a siemens automation informatics specialist for use in their new centralink.Hsc reviewed system files and logs received from the customer.Hsc verified that configurations and rules were entered into the new system by siemens support per the settings documented in the customer workbook.Upon review by siemens hsc specialist it was determined that the customer had changed the units for reporting the microalbumin method but did not update the calculation on the spreadsheet.The default calculation in the customer workbook for microalbumin was in mg/dl (x1000 calculation), not mg/l (x100 calculation).In conclusion, the error was introduced into the customer maintained workbook by the customer.The instrument is performing according to specifications.No further evaluation of the device is required.

• 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 ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5998099
• MDR Text Key: 56443626
• Report Number: 2432235-2016-00590
• 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,Followup
• 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: 09/06/2016
• Initial Date FDA Received: 10/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates 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