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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM
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SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM Back to Search Results
Model Number CENTRALINK DATA MANAGEMENT SYSTEM
Device Problem Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2014
Event Type  malfunction  
Event Description
Patient sample results were displayed on a centralink data management system and one patient's sample identification (sid) was paired with the incorrect patient name.The test order for hemoglobin a1c was sent to the laboratory information system (lis) translator with the correct patient name.A glucose result was then sent to the lis translator with the incorrect patient name, and the hemoglobin a1c result was sent to the lis translator without any patient name.The patient whose name had incorrectly been sent to the lis translator with the glucose result of another patient was also tested for glucose, and the result obtained on the other patient's sample was lower.The incorrect result was not reported to the physician(s) due to the name being associated with the incorrect sid.There are no known reports of patient intervention or adverse health consequences due to one patient's sid being paired with the incorrect patient name.
 
Manufacturer Narrative
The customer contacted the siemens customer care center (ccc).The customer stated that lab technicians had been manually entering the test orders and demographics.The demographics for the sid had been entered incorrectly, which caused the error.The mistake was discovered and corrected and the centralink data management system was working correctly.The cause of one patient's sid being paired with the incorrect patient name was a user error.This system is performing according to specifications.No further evaluation of this system is required.
 
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Brand Name
CENTRALINK DATA MANAGEMENT SYSTEM
Type of Device
DATA MANAGEMENT SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE DIAGNOSTICS INC.
511 benedict ave
tarrytown NY 10591
Manufacturer (Section G)
SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.
chapel lane
registration number: 8020888
dublin, swords
EI  
Manufacturer Contact
cassandra kocsis
511 benedict ave
tarrytown, NY 10591
9145242687
MDR Report Key4334616
MDR Text Key14880840
Report Number2432235-2014-00725
Device Sequence Number1
Product Code JQP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
510(K)EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Health Professional
Type of Report Initial
Report Date 12/02/2014
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 NumberCENTRALINK DATA MANAGEMENT SYSTEM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/02/2014
Initial Date FDA Received12/16/2014
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 Number1
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