MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. EASYLINK INFORMATICS SYSTEM

Model Number 10487219

Device Problem Human Factors Issue (2948)

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

Event Date 07/14/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The customer granted remote connection for the ccc to review the easylink data.In reviewing the data for sample id (b)(4), it was found that the laboratory information system (lis) sent two different patient orders for one patient sample id.The ccc stated that easylink will query the lis for an order when the customer places the sample on the dimension exl 200 instrument.The customer placed sample id (b)(4) on the dimension exl 200 instrument.At this time, sample id (b)(4) received two orders, one from the correct patient and one from another patient.The results were transmitted to the lis.The sample was then sent to their second instrument and ran the correct order.The customer stated they may have mis-entered the information for the first patient.The cause of the incorrect order from a different patient being ran is from human error.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A customer reported that they scanned a patient sample (b)(4) on their dimension exl 200 instrument and the easylink informatics system sent a different order from a different patient to the instrument.The incorrect results were not released to the physician(s).The sample was then placed on the second dimension exl and ran the correct patient and tests.The samples were not reran and a corrected report was not sent out.There are no known reports of patient intervention or adverse health consequences due to a different order from a different patient being presented.

• Brand Name: EASYLINK INFORMATICS SYSTEM
• Type of Device: EASYLINK INFORMATICS SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5855190
• MDR Text Key: 51501403
• Report Number: 2517506-2016-00299
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/08/2016

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: 10487219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 08/08/2016
• 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