MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION VISTA 1500

Device Problem Mechanical Problem (1384)

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

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls were within acceptable range.The ccc specialist reviewed the results and calculation data and found integrated multi-sensor technology (imt) errors.A siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse found that the instrument was producing computer area network and unstable imt errors.The dilution check was failing relative bias and na was recovering >50.The cse replaced the imt module and aligned it.The cse ran check 1, dilution check and quality control, which were acceptable.The cause of the discordant, falsely elevated na result on patient samples is unknown.The instrument is performing within manufacturing specifications.No further evaluation of device is required.

Event Description

Discordant, falsely elevated sodium (na) results were obtained on patient samples on a dimension vista 1500 instrument.The discordant results were reported to the physician(s), who questioned them.The customer stated that the patient care was affected for some patients, however, there is no additional information.The samples were repeated on the alternate dimension vista instrument, resulting lower and matching the clinical picture of the patients.The corrected results from the alternate dimension vista instrument were reported to the physician(s).There are no reports of adverse health consequences due to the discordant, falsely elevated na results.

Manufacturer Narrative

Additional information (10/25/2017): a siemens headquarters support center specialist reviewed the instrument data, which was indicative of air in the system or a fluid flow problem.The air potentially produced "integrated multi-sensor technology (imt) measurement errors" and high fluid deltas observed around the time of the discordant results.Average sodium standard deviation (mv) above 0.01 mv was an indicator of a poorly grounded imt module, and will result in imt data unstable errors.The issue was resolved by replacing the imt module.The cause of the discordant, falsely elevated sodium results on patient samples is unknown.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• 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: shweta gulati ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242870
• MDR Report Key: 6946319
• MDR Text Key: 90237935
• Report Number: 2517506-2017-00755
• Device Sequence Number: 0
• Product Code: JGS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051087
• 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: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 1500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2015
• 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