MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL WITH LM; DIMENSION VISTA EXL WITH LM

Model Number DIMENSION EXL WITH LM

Device Problem Mechanical Problem (1384)

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

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics inc.(siemens) customer service engineer (cse) was dispatched to the customer site.The cse replaced the sample metering syringe tip and sample diluent, reran diluent check and did a 30-test precision with no outliers.The instrument was fully functional on departure and the issue was resolved by the actions performed by the cse.The cause of the discordant, falsely low sodium results is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

Discordant falsely low sodium results were obtained on a dimension exl with lm instrument.The initial results were not reported to the physician.The same samples were repeated on the same instrument with a lower result for patient 1 and a higher result for patient 2.The same samples were then repeated on an alternate dimension exl with lm.The repeat results were higher than the initial results.The repeat results from the alternate analyzer were reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low sodium results.

• Brand Name: DIMENSION EXL WITH LM
• Type of Device: DIMENSION VISTA EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: karl aebig ; 511 benedict avenue; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 6492941
• MDR Text Key: 72786774
• Report Number: 2517506-2017-00374
• Device Sequence Number: 0
• Product Code: JGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL WITH LM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/16/2014
• 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