MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

Model Number DIMENSION VISTA® 500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) on (b)(6) 2017.Quality controls (qc) resulted out of range on (b)(6) 2017, but were in range when last run on (b)(6) 2017.The customer replaced the integrated multi-sensor technology (imt) sensor, and the v-lyte diluent, but qc still resulted high.Ccc reviewed instrument data, which indicated multiple measurement errors occurred.Ccc instructed the customer to the new sensor with a "dummy" sensor, bleach the vent and ports followed by hot water, and autoalign imt module and imt probe.The customer reset the instrument and reran qc, which resulted within range.The ccc then instructed the customer to replace the "dummy" imt sensor with the original one.A siemens headquarters support center (hsc) specialist reviewed the escalation data and observes the following: the customer replaced the integrated multi-sensor technology (imt) sensor after off-peak activities, but qc still resulted high, which suggests an advanced clean may have been required.Hsc recommends following the software prompts for the proper loading of a new imt fluid.Data suggests that the new imt diluent bottle was not yet onboard when the system started priming, introducing air to the imt system.This air likely produced the e142 errors and high fluid deltas observed.Increase in frequency of negative fluid deltas starting on (b)(6) 2017 also suggests there may have been a maintenance need to resolve a clog or slow drain in the sample port.A siemens customer service engineer (cse) was dispatched to the customer site.The cse performed a power flush, prime of all fluids, alignment check , inspection of fluid dispense and imt mix test.Patient correlation was performed and the instrument was fully operational upon completion of service.Hsc recommends ensuring that the fluid bottles are firmly pressed down and seated on the canula when replaced to ensure no air is introduced to the imt system through the fluid lines.The cause of the discordant, falsely high sodium results is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.

Event Description

Discordant, falsely high sodium (na) results were obtained on patient samples on a dimension vista 500 instrument.The initial discordant results were reported to the physician(s).The same samples were repeated on an another dimension vista instrument, and recovered lower.The corrected results obtained on the alternate dimension vista instrument were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely high sodium results.

• Brand Name: DIMENSION VISTA 500
• Type of Device: DIMENSION VISTA 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; registration # : 1226181; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6579061
• MDR Text Key: 75616539
• Report Number: 2517506-2017-00498
• 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
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA® 500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2015
• 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